DEPARTMENT OF HEALTH & HUMAN SERVICES · See Instructions fotOMB Statement FORM APPROVED: OMB No. 0910-0543. Expiration Date: 1/31114 DEPARTMENT OF HEALTH AND HUMAN SERVICES 1. REGISTRATION

DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service

Kate Willson, reporter ICIJ 910 1ih St. NW ih Floor Washington, DC 20006

In reply refer to file: F12-5064

Dear Ms. Willson:

Food and Drug Administration 1401 Rockville Pike Rockville, MD 20852-1448

October 2, 2012

This is in reply to your Freedom of Information Act request of July 12, 2012, in which you requested all FDA Form 3356 filings for all tissue banks on the list you provided. Your request was received in the Center for Biologics Evaluation and Research on July 16, 2012. In a July 13, 2012 telephone conversation with Beth Brockner Ryan you clarified that you are interested in receiving the FDA Form 3356 for initial registration and either inactivation (if they now have inactive status) or the most recent 3356 submitted for those that are still active. I apologize for the delay of this response.

Enclosed are documents responsive to your request.

If you have any questions or if I can be of further assistance, please let me know by referencing the above file number. I can be reached by phone at 301-827-9832, by FAX at 301-827-3843, or by e-mail at [email protected].

Sincerely,

Catherine Wilusz, Consumer Safety Officer Access Litigation and Freedom of Information Branch, HFM-48 CBER/OCOD/DDOM

The Department of Health and Human Services' implementing regulations, 45 CFR 5.34, set forth the procedures for you to follow if you decide to appeal any adverse determinations regarding your request. You should file any such appeal within 30 days and address it to the Deputy Assistant Secretary for Public Affairs (Media), U.S. Department of Health and Human Services, 7700 Wisconsin Avenue, Suite 920, Bethesda, MD 20857.

See lnstructionsforOMB Statement FORM APPROVED: OMB No. 0910-0543. Expiration Date: 1131/14 .----------:D"'E"'P:-:A-::R:::;T::-M:::E::-N:::;Tc;O:c;F'"'H"EA:=-::-:l-:To:-H:-A:-:N-:;D::-:-:H:-:U:-:MA=N-,S"'E"'R::-V;;:IC"'E'"'S:-----------r-1-R-E--:G-,-ISc-:T:--R-A'"'T-:-IO-:---:N-cN::-U-::-Mc::B:-:E::R:------

1,-,-..2-,, R"'EA""'S"'O'-N""F"o"R's"U"B"M'"'ISSiON --·--r--··v.i\LiDATION FOR FDA USE ONLY ' '

PUBLIC HEALTH SERVICE . (FDA Establishment ldentiOe<) a. p ___ -. INITIAL REGISTRATION I LISTING ~ VALIDATED ~y FDA:18-NOV-2009 FOOD AND DRUG ADMINISTRATION b. LJ ANNUAL REGISTRATION I LISTING, DISTRICT. lnt I Operal<ons Group

ESTABLISHMENT REGISTRATION AND LISTING FOR HUMAN CELLS, TISSUES, FEI: 3007015945 r;;] PRINTED BY FDA:12-JUL-2012 AND CELLULAR AND TISSUE-BASED PRODUCTS (HCT/Ps) c. I~J CHANGE IN INFORMATION INACTIVE

(See reverse side for instructions) d. IX I INACTIVE ~~ -PA_R_T_I ___ E_s_T_A_B_L_I_s_H_M_E_N_T-IN_F_o_R_M-'-A-T-Io_N___ ---------~RT n-:. PRODUCT INFORMATION -- -------------------- I !;iii:~ I ~~;; i j3~-oiiiE'R-i'iiA.-R'EGisl'RATION_s __________ ---------------- 10. ESTABLISHMENT fUt..lcnONs AND TYPES OF HCT I Ps _________ ~~=---1 S~gi ~~g~-

a. BLOOD FDA2830 NO. L_____-~-~ _ ~stablishm~nt Functions_ :::~Jt ~~~ ---------- -------- es ofHCT P

1 , 1 •

1 I I Q z ~~ I DEVICES FDA 2891 NO. Typ I 5 Recover' Screen ! Test Package I Process 1 Store Label ;mstrlbutc ~ ~~:n i

I I I ! til :

1 1 1 , i ; C, DRUG FDA 2656 NO. ----~~-- i I I I :

~~~!3 rCG'l::x: oClCn

~~~:g ;r:.:::Om~'~~ r o 0 ,.

"' "' c

" "'

14. PROPRIETARY NAME(S)

' post office code) ! 1 __j_ 1 _ • ~- PHYSIC/i~i:-LOCATION"(J;"Cludei;;Q-ai·~~me: n~mb~r~arKf street, city, state, country, and a Bone X II X- I --- I X II I X ±+-- ;

Krivoy Rog Department ofDnepropetrovsk Regional FM Bureau (KRl) ~----~~--~-~f---xf ~-X I I x ~---- -- ---1--X- ~-- -----~ --~-------____jl'

Ordzhonikidze Street-2 Dnepropctrovsk Region Krivoy Rog, 50051 Ukraine

b Cart1lage 1 I . I I 1 I I I : I

c. Cornea I d. Dura Mater

r-- ----e. Embryo [J Directed

CSIP I a. PHONE 49913499880 EXT I -----~--[:]Anonymous 1 b.o SATELLITERECOVERYESTABLISHMENT l -

1

- . ---~--+-~------------j J (MANUFACTURING ESTABLISHMENT FEI NO. : f. Fascia X X ] X ' ! X 1

':~;;;~,;;"C~"""'__ ...... ... ;-:=~ ---::::;1: X X j . XL -'_:__ X ,_:_: - ~----=-------_j ' [] SIP 'I t I I I

6. MAILING ADDRESS OF REPORTING OFFICIAl (Include institution name if applicable, '- Oocyle 0 Directed i ' number and street, city. state, country, and post office code) 0 Anonymous j I 1 I I

I Attn: Cheryl L. Bagwell J Pencardlum I X I X X I X ____j RTI Biologics, Inc. -- ~ 1

1 t 1 ---- -----j 11621 Research Circle k-Penphe-;;.1---t;JAutoiOgous --~----- - -- nT_l___________ I

I A'ooh,.FlmiU6<; )~'=~cJ::=,:'] X X i _ __l___j x_: _ L- ---xrr-r--~---~--~~====~-=-1 ENTER CORRECTIONS TO ITEM 6 . CL~O!'Ymou~- . ' I ~ I i":ISIP ~: M' ' I : I I ! ]

-...£'1::l0NE 386-418-8888 EXT 4564 _____ ~---~---- -·-------1 m. Semen o_ Directed I_ I 1 :. . I . b. PHONE l n. Skin .. .. l_x ___ ~l___ _L __ ---·x-r- ----~~J--t~---j~----------~

8. U.S. AGENT Ch~ryli:.- Bagwell

RTI Biologics, Inc. 11621 Research Circle, Alachua, Florida 32615

l 0

~~£~~t!l §~~:~:~i~ated! ----~ ~j ___ ---1---t-~ ~- _l __ j•l: ____ ~ _____ L_ ___ I 11 p. Tendon j X i X I I X [ i X i I -+--; j: J I I ~~ r--q~:~~~:~-----~~~~I:::~r--~-- -----~------·--_- --------·l'-------··r·-+1·--: -~ I i I : u Allo~e."_ei(O_ --~_! I I : : ~

I a. E-MAIL [email protected] r-9. RE-PORTING oFFICIAL's siGNATURE I

I a. TYPED NAME Cheryl L. Bagwell

· b. E-MAIL [email protected]

c. TITLE Director oiCompliance

FORM FDA 3356 (11/11)

L~:.Vasc~larGraft i . I ~-, -~---r-·--T- r. l . .. ---- I : s. I . l ~-~- I d-1------ ------------l

': I I f+i--1 : -l 386-418-8888-4564

d. DATE 08-DEC-2009

See Instructions fotOMB Statement FORM APPROVED: OMB No. 0910-0543. Expiration Date: 1/31114

DEPARTMENT OF HEALTH AND HUMAN SERVICES 1. REGISTRATION NUMBER -f·R~SON FOR SUBMISSION VALIDATION FOR FDA USE ONLY ------;---1 PUBLIC HEALTH SERVICE (FDA E'labH,hmeollden"'ecl a. U INITIAL REGISTRATION I LISTING VALIDATED BY FDA:29-NOV-2011 I

FOOD AND DRUG ADMINiSTRATION r;;, DISTRICT lnt'l Operattons Group ESTABLISHMENT REGISTRATION AND LISTING FOR HUMAN CELLS, TISSUES, FEI: 3007016079 b. @J ANNUAL REGISTRATION I LISTING PRINTED BY FDA 13-JUL-2012

AND CELLULAR AND TISSUE-BASED PRODUCTS (HCT/Ps) c. L CHANGE IN INFORMATION (See reverse side for instructions) d. [J _INACTIVE __ ,i,__ ______ I

PA~T~L_~ESTABLISHMENT INFORMATION PA~! 11- PRODUCT INFORMATION __ _ ______ _J

3_ OTHER FDA REGISTRATIONS 10. ESTABLISHMENT FUNCTIONS AND TYPES OF HCT IPs i a. BLOOD FDA 2830 NO. ---h-~~-----~~Est.ablishment Functions _ l 14. PROPRIETARY

---- --, ' I I --,-----------------,-------1 Q ': NAME(S) Types of HCT I Ps ! ! I z

b. DEVICES FDA 2891 NO. -----· ·.~=f:H~ Recover~. Smen Te" : Packago

1

Process i Store label iDist;lbUie ~ i

c. DRUG FDA 2655 NO. . : i I I ' I 4. PHYSICA-CLOcATION -(Include legal name, number and street. city, state, countrY, and - 4-- Ba . ~. X

1

1 ~ j X : •· x-:f--1 -_--+' ---+-----------~ past office code} \ a. ne . . ! I . i ----1

' Ivano-FrankovskRegionalForensicMedicalBureau(IF1) ~b. Cartilage ·~·-- , X X ., I --- X I_...... X ·~~-~ I Getman Mazepa Street 114 I c. Cornea 'I - 1 I I ! I ---t------ij----+------------, j lvan~-Frankovsk 76000 ~~- ..

1 J-.. '

1 1 '

j Ukrame d. Dura Mater I j I ! I

I OSIP i I . i

~ PHONE 49913499880 EXT e. Embryo B ~~~~~~ous i i , I I

b[J SATELLITERECOVERYESTABLISHMENT . -T-x-p=rx .. X j ~ 1 - (MANUFACTURING ESTABLISHMENT FEI NO I . I A I I [ l TESTING FOR MICRO-ORGANISMS ONLY : · ·- . ·-- , - -- ' ---1--------------------.j

ENTERCORRECTIONST61TEM4 ~-:-h-_L-,g-amen;--· [ x ~x! ; t-t' x .~-_ .. 1

___ r_:_x ___ l_~---~---------~---~ i---------~-16- MAILING AQORESS OF REPORTING OFFICIAL (!nclude institution name if applicable, ! number and street, city, state, country, and post office code)

RTI Biologics, Inc. Attn: Cheryl L Bagwell, CTBS 11621 Research Circle Alachua, Florida 32615

~ i.oocyte___ p~:~.cted '1 ~--~~ ~~ -~~--: --+~----! -- ~--r-----~ I 0 Anonymous I , / , '

r jPericardium - J-ijxj~-- J-~~n-· _]_: ! _ ! --] 1 k. Penpheral 0Auto!ogous ! l I i : T I I Blood Stem CJ Family Related I 1 ' ·, ~. ,

1 [_J Allogeneic ! : : 1 .

~-~-cler~ -----~--.. - -- i ~-----~~-~~~:~ ~~~~:~~~~~~~~~~~:~~~--------------!

"'""' m-=-=;;.~.-.Jl~ . X b I ; 1-:-~x : --~X I I I ·.~1 ~~~--:::-:::=-::---------)---'-'-"r•uu~uu:o J§l~~:=~~ate~ #• T I -1 I j .J 1

B-~~I~i:~:gic~~:z1LBagwell,CTBS p.Tend~:__----~------~_j__: x_ [ X

1

____ ~ ! : =· _",_P,'iONE 386-418-8888 EXT 4564 7. ENTER CORRECTIONS TO ITEM 6

' _ . ..., q. Umbilical ~Autologous ~ : 1 I \ : 11621 Research C1rcle, Alachua, Flonda ~2615 Cord Blood 0 Family Related . ] I 1 1 I 1 .

0 Allogeneic , I • 1

__::_~~ILc~agwell@rtixcom ___________ .. __ 386:~!_8-8888-4564 r.VascularGraft ______ .. _____ I ++= I 1 i .. J. I -==---~ 9.REPORTINGOFFICIAL'SSIGNATURE ~-· I IL-t+ ---, ill I !I . - --~

a. TYPED NAME Cheryl L. Bagwell, CTBS I u I I · -------b. E-MAIL [email protected] I I I l J I !

, c_ TITLE Compliance Manager d_ DATE 28-NOV-2011 ~-;---- -~ -- I --~ ! ! I - , , . ' I - .

FORM FDA 3356 (11111)

DEPARTMENT OF HEALTH AND HUMAN SERVICES PUBLIC HEALTH SERVICE

FOOD AND DRUG ADMINISTRATION ESTABLISHMENT REGISTRATION AND LISTING FOR HUMAN CELLS, TISSUES,

AND CELLULAR AND TISSUE-BASED PRODUCTS (HCT/Ps)

1. REGISTRATION NUMBER (FDA Establishment Identifier)

FEI: 3007016079

(See reverse side for instructions) ·---·-·--- ·----'----------'---·---------·

ADDITIONAL INFORMATION:

Authorization Letter from Ministry of Health of Ukraine Bioimplant is on file at Tutogen Medical, Inc. a wholly owned

subsidiary ofRTI Biologics, Inc. in Alachua, Florida location. This letter allows Karl Koschatzky, President ofTutogen Medical, GmbH, in Ncunkirchen, Gem1any to register the Ukraine recovery sites with the FDA. Please contact Cheryl Bagwell for a copy if necessary.

Tutogcn Medical, Inc. a wholly owned subsidiary ofRTI Biologics, Inc.

Proprietary Name(s):

FORM FDA 3356 (11/11)

See Instructions for OMB Slatement FORM APPROVED: OMS No. 0910-0543. Expiration Date: 1/31114

·-·--···--···--·--····--·--------------

____ ..1 Page:2

See 1ns:ructions forOMB Statement FORM APPROVED: OMB No. 0910-0543. Expiration Da1e: 1131/14

/ DEPARTMENT-OF HEAL T"'H-:--cA"N"'D-cHccUccM.,A:-:Nc-S:oE~R00V-;;I:oC:o:E:::S------------.-1-. R_E_G_I_S_T_RA_T-IO_N_N_U_M_B_E_R ______ I,-,2'."R""I:..._..-A""S"O"N"F"'O"R SUBMISSION VALIDATION--FOR FDA USE ONLY 'L PUBLIC HEALTH SERVICE . (FDA E'labti,hmeot ldeo!iOer) II a. [·..J·····. INITIAL REGISTRATION I LISTING VALIDATED BY FDA:29-NOV-2011 FOOD AND DRUG ADMINISTRATION o· ANNU L EG TRATIO I LIST DISTRICT: lnfl Operations Group

ESTABLISHMENT REGISTRATION AND LISTING FOR HUMAN CELLS, TISSUES, FEI: 3008834200 b. r.;;: A R IS N lNG I PRINTED BY FDA:t3-JUL-2012 AND CELLULAR AND TISSUE-BASED PRODUCTS (HCT/Ps) 1 c.LKJ CHANGE IN INFORMATION ]INACTIVE

(See reverse side for instructions)________ --------- j ___ ~.:_~-J~.f'CTIVE ------.------------1 PART 1- ESTABUSHMENTINFORMATION - L..J'A~_T)I- PRODUCTINFORMATlON ----------- ~~=I ~~;;;~ 5~~~1

13. OTHERFDAREGISTRATIONS ]_1!J__,_l:_§_TABLISHMENTFUNCTI()J'jS~_[)_l}'Pg_§_QfHCT/Ps -·----·-- _j ~~~~ ~:;~ 1 g~i=~] a.BLOODFDA2830 NO. I I EstablishmentFunctions ~~~~ ~~~~ 0~~~~ b. DEVICES FDA 2891 NO. ------~----------------------- Types of HCT IPs 1 Recover 1 Screen I Test ~-Package Process Store Labcl o;,t.-ibutc = ~ l ~~ I ~ ~ .

I 'Cll I Ci} I

c ···: - X t X I' I L X i • .~ I" J_L c. DRUG FDA 2656 NO.

--------·~

4. PHYSICAL iOCAT(ON (Include legal name, number and street, city, state, country, and post office code)

Nikolaev Regional Bureau of Forensic Medical Examination (NlKl)

14. PROPRIETARY NAME(S}

Potcmkinskaya Street 13 8 Nikolaev, 54003 U!aaine

i b. Cartilage X 1 X J I X i i X ~ i

~~ •• :.~. ' I I I i I I I ·----~ c. Cornea

S ~:::cted ;

1

1 I I :===R=J' b 0 SATELLITE RECOVERY ESTABLISHMENT . . [J Anonymous I i -~~ 1-~

-~(MANUFACTURING ESTABLISHMENT FE! NO. f. Fascia X 'R=X X I X ! c. lJ TESTING FOR MICRO-ORGANISMS ONLY - --- --- --r- - -- --

h,- -------~--- "~·--------"-- g. Heart Valve ~ j I I I : ) 15. ENTER CORRECTIONS TO ITEM 4 f---------------·-··· ___ r _[_ -·---- _; __ _[_ ___ I

h. Ligament X I X i X I I Y I _ ___j [] SIP f-- ---:---- ---

6. MAILING ADDRESS OF REPORTING OFFICIAL (Include institution name if applicable, I i. Oocyte q Directed I I

number and street, city, state, country, and post office code) L J Anonymous ~~ ~----- +'---+' ---+-RT! Biologics, Inc. j. Pericardium X X r I=] X L Attn: Cheryl L Bagwell, CTBS ·--' I 1 1!621 Research Circle k. Peripheral r::;JAutologous 1 Alachua Florida 32615 Blood Stem D Fam;ly Related 1 , ,..""-----·- I

D SI-P ____ j___ll t i ' I Tl' ______ : Dl, +I __ ~~-~ ____ J m. Semen El_~;~~~ous . ---~---~ -= i _ ~±+---

:~;.~" RE?:::~,' X ~~~-+ I ' X 18±1 X I ~---·-----~ s. u.s. AGENT Cheryl L. Bagv,·eu, CTBS ·--·-·-·---·-·-·--- p. Tendon-- . x I x -- -- -r I x -i·--- ---I x I l' ----·--------···--~

RTI Biologics, Inc. .. -------- I __ r--- __ , ~---q. Umbtllcal Autologous 1 I I i I I

11621 Research Circle, Alachua, Florida 32615 Cord Blood ::J Family Relatec I 'I I I ' . . ! : i U Allogeneic 1

386-418-8888-4564 rr. Vascular Graft·-·-----.. 1- ··-··· ! I I -- _____ L_____ ~----- --: -41=--. L i I I t ·i I __ ]!____ i - i I . --·-·---:

-------- -----,--·--- .. ·-·-+-----: . ______ _j

~;---- - i I 1- ·-· -· ·I i I r-------------------1

e. Embryo

a. PHONE 49913499880 EXT

I. Sclera

a. PHONE 386-418-8888 17. ENTER CORRECTIONS TO ITEM 6

EXT 4564

b. PHONE

. _.::._E.::_~_'!\~~~~"_~.':!~@~~~=~~--------9. REPORTING OFFICIAL"S SIGNATURE

a. TYPED NAME Cheryl L. Bagwell, CTBS

b. E-MAIL [email protected]

c. TiTLE Compliance Manager d. DATE 16-APR-2012

FORM FDA 3356 [11/11)

See lns1ructions for OMS Statement FORM APPROVED: OMS No. 0910-0543. Expira6on Date: 1/31/14

DEPARTMENT OF HEALTH AND HUMAN SERVICES I 1. REGISTRATION NUMBER 2. REASON FOR SUBMISSION ! VALIDATION-FOR FDA USE ONLY

1 I PUBLIC HEALTH SERVICE l (FDA Establishment ldentif.er) a. 0 INITIAL REGISTRATION I LISTING VALIDATED BY FDA:29-NOV-2011

FOOD AND DRUG ADMINISTRATION b.liJ ANNUAL REGISTRATION I LISTING DISTRICT: lnt'l Operations Group ESTABLISHMENT REGISTRATION AND LISTING FOR HUMAN CELLS, TISSUES, FEI: 3000070847 PRINTED BY FDA:27-JUL-2012

AND CELLULAR ANO TISSUE-BASED PRODUCTS (HCT/Ps) c. D CHANGE IN INFORMATION I

{S-ee reverse side for instrtJctlons) d.n INACTIVE I

PART I -ESTABLISHMENT INFORMATION PART II ·PRODUCT INFORMATION no~ ~~11 ~o~~ Tim;:->' mm!-1 o::am~

3. OTHER FOA REGISTRAllONS 10. ESTABLISHMENT FUNCTIONS AND TYPES OF HCT IPs \ ~£~ oGl::t: ,...c:o:r. oco ooco

Establishment Functions I~~~ :t-):::i om~::::! 14. PROPRIETARY

a. BLOOD FDA2830 NO. ~~~~ ~gg~ NAME(S)

Types of HCT I Ps Scrw•n J, Test 1·-· 2 S> I o > b. DEVICES FDA 2891 NO. Recover Proc;oss Storo Labol Distributo ~ oc.o I ?J m

m " i "' " "' I c. DRUG FDA 2656 NO. I

I 14. PHYSICAL LOCAllON (Include legal name, number and street, city, state, country, and a. Bone X X X X post office code)

Dneprodzerzhinsk Department ofDnepropetrovsk Regional FM Bureau b. Carti"ge X

(DN2) X

\ X X

Stree Anoshkina 67-2 I I I

Dnepropetrovsk Region c.Comea

Knoprodzerzhinsk. 51917 d. Dura Mater i i Ukraine

OSIP I I

e. Embryo 0 Directed I a. PHONE 49913499880 EXT 0 A.nonvmous

b.o SATELILITE RECOVERY ESTABLISHMENT f. Fascia X X I I X X

o(MANUFAC11JRING ESTABLISHMENT FEI NO. c. TESTING FOR MICRO-ORGANISMS ONLY

5. ENlER CORRECTIONS TO ITEM 4 g. Heart Valve

h. Ugament X X X X

OSIP

I 6. MAILING ADDRESS OF REPORTING OFFJCIAL Qnclude institution name a applicable, i. Occyte 0 Directed

I number and street. city, state, country, and post office code) 0 Anonymous

RTI Biologics, Inc. j. Pericardiurr, X X I X X I Attn: Cheryl L. Bagwell, CTBS I

11621 Research Circle k. Peripheral 0 Autologous ! Alachua, florida 32615 Blood Stem 0 Family Related

0 Allogeneic I I I

I. Sclera

0SIP

I I I

a. PHONE386-418-8888 EXT4564 m. Semen 0 Directed ! 7. ENlER CORRECTIONS TO llEM 6 0Anonvmous

b. PHONE ! I X

I

n. Skin X X X I !

o. Somatic Cell 0 Autologous I I I Therapy R;:=rRelated I

I I

Products AI ene·lc

8. U.S. AGENT Cheryl L. Ba.,owell, CTBS p. Tendon X X X X I I RTI Biologics, Inc.

11621 Research Circle, Alachua, Florida 32615 q. Umbilical g Autologous I I

I I Cord Blood 0 Family Related I i I 0 Allogeneic j I I

i 1 I a. E-MAIL [email protected] 386-418-8888-4564 r. Vascular Graft i I

9. REPORTING OFFICIAL'S SIGNATURE s. i I I

I. i I a. TYPED NAME Cheryl L. Bagwell, CTBS I

u. I

I I b. E-MAIL [email protected] I

c. TITLE Compliance Manager d. DATE 28-NOV-20!1 v. I I I I

i I I

FORM FDA3356 (11111)



AND CElLULAR AND TISSUE-BASED PRODUCTS (HCT/Ps) (See reverse side for instructions)


Authorization Letter from Ministry of Health of Ukraine Bioimplant is on file at T utogen Medical, Inc. a wholly owned

subsidiary ofRTI Biologics, Inc. in Alachua, Florida location. This letter allows Karl Koschatzky, President ofTutogen Medical, GmbH, in Neunkirchen, Germany to register the Ukraine recovery sites with the FDA Please contact Cheryl Bagwell for a copy if necessary.

Tutogen Medical, Inc. a wholly owned subsidiary ofRTI Biologies, Inc.


FORM FDA3356 (11111)

1. REGISTRATION NUMBER (FDA Establishrnenlldentifier)

FEI: 300007084 7

Sea Instructions for OMB Sbtement FORM APPROVED: OMB No. 09,0-0543. Expiration Date: 1/31/14

Page:2

See Instructions forOMB Statement FORM APPROVED: OMB No. 0910-0543. Expiration Date: 1/31/14

' DEPARTMENT OF HEALTH AND HUMAN SERVICES I 1. REGISTRATION NUMBER 2. REASON FOR SUBMISSION I VALIDATION FOR FDA USE ONLY 1

PUBLIC HEALTH SERVICE i (~OA Establishment Identifier) a. 0 INITIAL REGISTRATION I LISTING , VALIDATED BY FDA:03·DEC-2008 FOOD ANO DRUG ADMINISTRATION b. 0 ANNUAL REGISTRATION I LISTING I DISTRICT: lnt'l Operations Grouo

i ESTABUSHMENT REGISTRATION AND LISTING FOR HUMAN CELLS, TISSUES, FEI: 3004554625 ' PRINTED BY FDA:27-JUL-2012

AND CELLULAR AND TISSUE-BASED PRODUCTS (HCT/Ps) c. ~ CHANGE IN INFORMATION INACTIVE

(See reverse side for instructions) d.lxl INACTIVE

PART 1- ESTABLISHMENT INFORMATION PART II- PRODUCT INFORMATION oo~ I ~~- roo::o .... ~~; {g~~ ~~~;

3. OTHER FDA REGISTRATIONS 10. ESTABLISHMENT FUNCTIONS AND TYPES OF HCT IPs ~~~ ~~~ oCCn Clu:.r--1

14. PROPRIETARY

I a. BLOOD FDA 2830 NO. Establishment Functions ~~~ ~;;\~ £~~~ NAME{S)

Recover I Sc:;reen Label ! Olstribute-

cO me ,.. 0

Types of HCT I Ps z l :=)lo 0 > b. DEVICES FDA 2891 NO. Tost Pot.c::~ge Process Storn !:! i ~(ll ;!,! "'

I l"' ~ I

C. DRUG FDA 2656 NO. 1

4. PHYSICAL LOCA TlON (Include legal name, number and street, city, state. country, and

I ' I

post office code) a. Bone

State Scientific Manufacturing Enterprise Bioimp!ant l

I I b. Carulage I

I

Patrice Lumumba Street-4/6 c. Cornea I Building A Kiev. 01042 d. Dura Mater I

I

Ukraine Ds1P

I I

I

e. Embryo D Directed a. PHONE 38-044-206-0507 EXT D Anonvmous

b.Q SATELLITE RECOVERY ESTABLISHMENT f. Fascia I D[MANUFACTLIRlNG ESTABLISHMENT FEI NO.

c. TESTING FOR MICRO-ORGANISMS ONLY I \

I

g. Heart Valve I I ! I 5. ENTER CORRECTIONS TO ITEM 4 I

I ' I h. Ligament I

I Ds1P i I

I 6. MAILING ADDRESS OF REPORTING OFFICIAL (Include insmution name if applicable. i. Oocyte D Directed

I number and street, city. sta1e, country. and post office code) D Anonymous I State Scientific Manufacturing Enterprise Bioimplant

j. Pericardium ~ Attn: Igor Aleshchenko i Patrice Lumumba Street- 416 k. Peripheral D Autologous

Building A BloodS'""" D Family Reiated

Kleve, 04ll2 OAJiogeneic I

I Ukraine I. Sclera I

I l 0SIP

I i I

a. PHONE 38-044-206-0507 m.Semen BDireded I

EXT I 7. ENTER CORRECTIONS TO ITEM 6 Anonymous I b. PHONE

f n.Skin

··- ---o. Somatic: Cell ~AUtologous

I Therapy A 'Family Related Products Alloqeneic I

S. U.S. AGENT CarrieHartill - i p. Tendon i Regeneration Technologies, Inc (RTI) I q. Umbilical ~Autologous I

11621 Research Circle, P.O. Box 2650, Alachua, Florida 32615 Cord Blood 0 Family Related 0AIIogeneic

a. E-MAIL [email protected] 386-418-8888 r. Vascular Graft

9. REPOR11NG OFFICIAL"S SIGNATURE I S.

t

a. TYPED NAME Igor Ateshchenko

b. E-MAIL [email protected] u.

I I c. TITLE Director d. DATE 22-JUN-2004 v. I I I FORMFDA3356 (11/11)

I DEPARTMENT OF HEALTH AND HUMAN SERVICES PUBLIC HEALTH SERViCE

FOOD AND DRUG ADMINIS1RAllON ESTABLISHMENT REGISTRATION AND LISTING FOR HUMAN CELLS, TISSUES,

AND CELLULAR ANO TISSUE-BASED PROOUCTS (HCT/Ps) (See reverse side for instructions}


This is a duplicate registration. YF


FORM FDA3356 (11111)


FEI: 3004554625

See InstructiOns for OMS Sta.tement FORM APPROVED: OMB No. 0910-0543. Expiration Date: 1/31/14

Page:2

See Instructions. for OMB Statement FORM APPROVED: OMB No. 0910-0543. Expiralion Date: 1131114

DEPARTMENT OF HEALTH AND HUMAN SERVICES 1. REGISTRATION NUMBER I 2. REASON FOR $0BMISSION VALIDATION-FOR FDA USE ONLY PUBLIC HEALTH SERVICE (FDAEstablish'""ntldenHfier) , a. 0 INITIAL REGISTRATION I LISTING VALIDATED BY FDA:29-NOV-2011

FOOD AND DRUG ADMINISTRATION ~· b OO ANNUAL REGISTRATION I LISTING DISTRICT: lnt'l Operations Group ESTABLISHMENT REGISTRATION AND LISTING FOR HUMAN CELLS, TISSUES, FEI: 3007014307 .

0x PRINTED BY FDA:27-JUL-2012

AND CELLULAR AND TISSUE-BASED PRODUCTS (HCT/Ps) c. CHANGE IN INFORMATION (See reverse side for instructions) __ _!l'~_D INACTIVE

PART 1- ESTABLISHMENT INFORMATION PART II- PRODUCT INFORMATION i !;~~;!I i'ii~;J !!!~~;; ;:;QCR cC Oc:Cl-

3. OTHERFDAREGISTRATIONS 10. ESTABLISHMENTFUNCTIONSANDTYPESOFHCT/Ps 1 ;;£~ oc~ 5"'~n • • ' :!,Qj~ >~:::l !!![.Q:t>:j

a. BLOOD FDA2830 NO. Establishment FunctiOns : :.,.m.., j ~itli? ogrri; ! 0 ~ ~0 ;:. 0

Types of HCT J Ps R(>cover Sc;.-..n Test lj Package Process St(lre Ub-AI DlstrfDutol ~ j ~ ~ ~ ~

I I ~ ~ I b. DEVICES FDA 2891 NO. __________________________ __

c. DRUG FDA 2656 NO.

4. PHYSICAL LOCATION (Include legal name, number and street, city, state, country, and post office code)

Gorlovka Department ofDonetzk Regional FM Bureau (GORI)

Lenin Prospect- 26 Donetzk Region Gorlovka, 84601 Ukraine

a. PHONE 49913499880 EXT b.o SATELLITE RECOVERY ESTABLISHMENT

c. d~~~~~~c~~~~?c~~~~~~~~ 6!~ ~o .. _________ __ 5. ENTER CORRECTIONS TO ITEM 4

6. MAILING ADDRESS OF REPORTING OFFICIAL (Include institution name if applicable. number and street, city, state, country, and post office code)

RTI Biologics, Inc. Attn: Cheryl L Bagwell, CTBS 11621 Research Circle Alachua, Florida 32615

a. PHONE 386-418-8888 EXT4564 i 7. ENTER CORRECTIONS TO ITEM 6

b. PHONE

B. u.s. AGENT Cheryl L Bagwell, CTBS RTI Biologics, Inc. 11621 Research Circle, Alachua, Florida 32615

a. E-MAIL [email protected] S. REPORTING OFFICIAL'S SIGNATURE

a_ TYPED NAME Cheryl L. Bagwell, CTBS

b. E-MAIL [email protected]

c. TITLE Compliance Manager

FORM FDA 3356 {11/11)

386-418-8888-4564

d. DATE 28-NOV-2011

a. Bone

b. Cartilage

c. Cornea

d. Dura Mater

e. Embryo

f. Fascia

g_ Heart Valve

h. Ligament

i. Oocyte

j. Pericardium

k. Peripheral Blood Stem

I. Sclera

m. Semen

n. Skin

o_ Somatic Cell Therapy Products

p. Tendon

OSIP 0 Directed 0 Anonymous

0Autologous 0 Family Related 0 Allogeneic

OSIP 0 Directed OAno~s

0 A~tologous I 0 Family Related OAIIOQeneic

q. Umbilical LJ Autologous Cord Blood 0 Family Related

0AIIogeneic

r. Vascular Graft

s,

l

u.

V.

X X t ! I X I : X I I

X X

X X

X I X

X X

X X

X

X

X

X

X

ix !

I X

X

X

X

i X

I

14. PROPRIETARY NAME(S)

, I i



AND CELLULAR AND TISSUE-BASED PRODUCTS (HCT/Ps) (See reverse side for instructions)

ADDITIONAL INFORMATION;


subsidiary of RTI Biologics, Inc. in Alachna, Florida location. This letter allows Karl Koschatzky, President ofTutogen Medical, GmbH, in Neunkirchen, Germany to register the Ukrcine recovery sites with t.l,e FDA. Please contact Cheryl Bagwell for a copy if necessary.

Tutogen Medical, Inc. a wholly owned subsidiary ofR TI Biologics, Inc.


FORM FDA3356 (11111)

1. REGISTRATION NUMBER (FDA Esbbllshmon~ lderr\Jfic.r)

FEI: 3007014307

See lnstruc;tjonsfor DMB Statement FORM APPROVED: OMB No. 0910-0543. Expira1ion Date: 1/31/14

2

It

I

Page:2

Soe Instructions: for OMB S~t!!!ment FORM APPROVED: OMB No. 0910-0543. Expira~on Date: 1131114 DEPARTMENT OF HEALTH AND HUMAN SERVICES 1. REGISTRATION NUMBER I z. REASON FOR SUBMISSION VALIDATION-FOR FDA USE ONLY 1

PUBLIC HEALTH SERVICE (FDA Establishmertt Identifier) a. 0 INITIAL REGISTRATION I LISTING VALIDATED BY FDA:19-NOV-2009 FOOD AND DRUG ADMINISTRATION I b. 0 ANNUAL REGISTRATION I LISTING DISTRICT: lnrl Operations Group

ESTABLISHMENT REGISTRATION AND LISTING FOR HUMAN CELLS, TISSUES, FEI: 3007014378 PRINTED BY FDA:27-JUL-2012 AND CELLULAR AND TISSUE-BASED PRODUCTS (HCT/Ps) I c. 00 CHANGE IN INFORMATION INACT1VE

(See reverse side for instructions} d. i1J INACTNE

PART 1- ESTABLISHMENT INFORMATION PART II- PRODUCT INFORMATION no~ """ I DJO;D~ "'Tim:-" mm ! g~g~ 13. OTiiER FDA REGISTRATIONS "'"'"' "" 10. ESTABLISHMENT FUNCTIONS AND TYPES OF HCT IPs ~g~ ~~ l gUJ>g

a. BLOOD FDA 2830 NO. Establishment Functions ~~~ r_, I oo~""':: 14. PROPRIETARY oO om >;JJmlll NAME(S)

RQeoY•r J Screen i me r 0

Types of HCT I Ps z ,,. c ,. b. DEVICES FDA 2891 NO. Test I Poe••~ ProCiiiSS Sto"' Labol Oistributa

1 ~ E(Q "' .. c: I ~ I


4:Pi:ffsicAL LOCAnON (Include legal name, number and stree~ city, state, counll)l, and I

a. Bone X X X X I post office code)

Pathological Department of the Kiev City Clinical Hospital No. 3 (KV5) b. Cartilage X X X I X

Petra Zaporozhtsa Street- 26 c. Cornea ! Kiev, 04125

Ukraine d. Dura Mater l ! ~ ! 0SIP

I I I

! e. Embryo D Directed I

a. PHONE 499!3499880 EXT 0 Anonymous I b.o SATELLITE RECOVERY ESTABLISHMENT t Fascia X X I X i X o(MANUFACTIJRiNG ESTABLISHMENT FEI NO. ! c. TESTING FOR MICRO-ORGANISMS ONLY I g. Heart Valve )

5. ENTER CORRECTIONS TO ITEM 4 I h. ligament X X I X X

I D SIP ; I I

6. MAILING AllDRESS OF REPORTING OFFICIAL (Include institution n2me if applicable, i. Oocyte 0 Directed l I number and street, city, state, cour.try, and post office code) D Anonymous RTI Biologics, Inc.

j. Pericardium X X X i X i Attn: Cheryl L. Bagwell, CTBS I I

I I !1621 Research Circle k... Peripheral 0Autologous

Alachua, Florida 3 2615 I BloodStem 0 Famiy Related I 0AIIogeneic I

I. Sclera X X X X

0SIP

I I a. PHONE 386-418-8888 EXT 4564 m. Semen 0 Directed

7. ENTER CORRECTIONS TO ITEM 6 0 Anonymous b. PHONE I n. Skin X X X X I

o. Somatic Cell D Autologous [ Therapy R Family Related

Products Allooeneic I

8. U.S. AGENT Cheryl L Bagwell p. Ter<lon X X X X RTI Biologics, Inc.

11621 Research Circle, Alachua, Florida 32615 q. umbilical b! Autologous

I Cord Blood Q Family Related 0 Allogeneic • ·--.

a. E-MAIL [email protected] 386-418-8888-4564 r. Vascular Graft

9. REPORTING OFFICIAL'S SIGNATURE s.

t

a. TYPED NAME Cheryl L. Bagwell, CTBS u. I

b. E-MAIL [email protected] I c. TITLE Director of Compliance d. DATE 08-DEC-2009 v. I I I

I

i FORM FDA 3356 (11/11)

See Instructions for OMB Statemen: FORM APPROVED: OMB No. 0910.{)543. Expiration Date: 1131114

DEPARTMENT OF HEALTH AND HUMAN SERVICES 1. REGISTRATION NUMBER 2. REASON FOR SUBMISSION I VALIDATION-FOR FDA USE ONLY 1 I

PUBLIC HEALTH SERVICE (FDA Estabtishmel"'t Identifier) a. 0 INITIAL REGISTRA llON I LISTING VALIDATED BY FDA:29-NOV-2011 ! FOOD AND DRUG ADMINISTRATION b.IX] ANNUAL REGISTRATION I LISTING DISTRICT: lnt'l Operations Group

I ESTABLISHMENT REGISTRATION AND LISTING FOR HUMAN CELLS, TISSUES, FEI: 3007014431 c. D CHANGE IN INFORMATION

PRINTED BY FDA:27-JUL-2012 AND CELLULAR AND TISSUE-BASED PRODUCTS (HCT/Ps}

(See reverse side for Instructions) d. n INACTIVE

PART 1- ESTABLISHMENT INFORMATION PART II- PRODUCT INFORMATION ~~::: .,,_ mc:::o-

I m!TI~ Q;:JJm!-"

3. OTHER FDA. REGISTRATIONS "'"':. c<>z ,..c:Q:r: 10. ESTABLISHMENT FUNCTIONS AND TYPES OF HCT IPs -"o c;c:o at:~ co

~~~ ~E:g om•..;

a. BLOOD FDA 28:30 NO. Establishment Functions gg~~ 14. PROPRIETARY om• NAME(S)

' Pockagel P«><=s lahol I Distribute

oc mo r 0

Types of HCT I Ps Recover j Scroen z :S> 0 l:;

b. DE.VICES FDA 2891 NO. Test Storo " "'"' "' ~ c ! " "' c. DRUG FDA2656 NO.

i ' i I"· PHYSICAL LOCATION (Include legal name. number and s~eet, city, state, counlry, and

a. Bone X X I X X I post olfoce oode) ' ' State Enterprise Bioimplant of Ministry of Public Health ofUkraine b. cartilage X i X X X

·Patrice Lumumba Street c. Cornea I 4/6, Building A, Office 310 ! ' IGev, 01042 d. Dura Mater ' i

! Ukraine l 0SIP

I e. Embryo 0 Directed

a. PHONE 499!3499880 EXT 0 Anonvmous

I b.o SATELLITE RECOVERY ESTABLISHMENT f. Fascia X X I X X

I D(MANUFACTURING ESTABLISHMENT FE! NO. I

C- TESllNG FOR MICRO-QRGANISMS ONLY I ! g. Heart Valve : 5- ENTER CORRECTIONS TO ITEM 4 I

h. Ligament X X X X I 0 SIP

16. MAILING ADDRESS OF REPORTING OFFICIAL (Include institution name ff applicable, i. Oocyte 0 Directed l number and street, city, state, country, and post of!ioe oode) 0 Anonymous I

RTI Biologics, Inc. j. Pericardium X X X X i Attn: Chetyl L Bag.vell., CTBS

' ll621 Research Circle k. Peripheral 0 Autologous

I Alachua, Florida 32615 Blood Stem 0 Family Related I U Allogeneic

I. Sclera

C!siP

I j a. PHONE 386-418-8888 EXT 4564 m. Semen 0 Directed

7. ENTER CORRECTIONS TO ITEM 6 !1 Anonvmous b. PHONE J

I n. Skin X X I X X I !

o. Somatic Cell 0Autologous I I

Therapy g;amily Related Products Allogeneic

8. U.S. AGENT Cheryl L Bag.vell, CTBS p. Tendon X X X X I I RTI Biologics, Inc. 11621 Research Circle, Alachua, Florida 32615

q. Umbilical ~Autologous I l Cord Blood 0 Family Related

0AIIogeneic I I a. E-MAJL [email protected] 386-4!8-8888-4564 r. Vascular Graft I

9. REPORTING OFFICIAL'S SIGNATURE s.

I I l

I I a. TYPED NAME Chetyl L. Bagwell, CTBS ' b. E-MAIL [email protected]

u. I \ I c. TITLE Compliance Manager d. DATE 28-NOV-2011 v. I i ~--

' i FORMFDA3356 (11111)






subsidiary of RTI Biologics, lnc. in Alachua, Florida location. This letter allows Karl Koscharzky, President ofTutogen Medical, GmbH, in Neunkirchen, Germany to register the Ukraine recovery sites with the FDA. Please contact Cheryl Bagwell for a copy if necessary.

Tutogen Medical, Inc. a wholly owned subsidiary of RTI Biologics, Inc.


FORM FDA 3356 (11/11)


FEl: 30070!4431

Se1Z lnstructi<lns for OMB Statement FORM APPROVED: OMB No. 0910...0543. Expiration Date: 1/31/14

Page:2

See lnslructiOI'I!; for OMS. St~temcnt FORM APPROVED: OMB No. 0910-0543. Expiration Date: 1131/14

DEPARTMENT OF HEALTH AND HUMAN SERVICES 1. REGISTRATION NUMBER 2. REASON FOR SUBMISSION VALIDATION-FOR FDA USE ONLY 1

PUBLIC HEALTH SERVICE (FDA Es1ablishroent Identifier} a. 0 INITIAL REGISTRATION I LISTING VALIDATED BY FDA:29-NOV-20'1 FOOD AND DRUG ADMINISTRATION b. 00 ANNUAL REGISTRATION I LISTING DISTRICT: lnt'l Operations Group

ESTABLISHMENT REGISTRATION AND LISTING FOR HUMAN CELLS, TISSUES, FEI: 30070146!7 D PRINTED BY FDA:Z?..JUL-2012 AND CELLULAR AND TISSUE-BASED PRODUCTS (HCT/Ps) c. CHANGE IN INFORMATION

(See reverse side for instructions) d. D INACTIVE

PART I- ESTABLISHMENT INFORMATION PART II- PRODUCT INFORMATION <10~ ;;;u i 5~~;! ""1'\n',;-" mm

3. OTI!ER FDA REGISTRATIONS 10. ESTABLISHMENT FUNCTIONS AND TYPES OF HCT IPs ;t~<r.x co rC:G1:;t

-"" ~~ 0 10:1c 0 ND-< 2~~~

a. BLOOD FDA 2830 NO. Establishment Functions ~~~ r_, 14. PROPRIETARY I o:: orn ~;:gfilltl NAME(S) mo r o

Types of HCT I Ps z ,,. 0 l>

b. DEVICES FDA 2891 NO. Rec:over SC<Oen Test ~ckage Process Storo Labt:\ IDislributt~ !:: ~co , .. c:

" " c. DRUG FDA 2656 NO.

4. PHYSICAL LOCAllON (Jnclude legal name, number and street, city, state, country, and a. Bone X X X X

post office rode) 1

Cherkassy Regional FM Bureau (CHI) 1 ' I

b. Cartilage X X X X

Dahnovskaya Street 32 c. Cornea

Cberkassv. 18009 I Ukraine d. Dura Mater

I I I

OSIP i J

e. Embryo 0 Direded a. PHONE 49913499880 EXT 0 Anonymous I

b.Q SA TELUTE RECOVERY ESTABLISHMENT I I i o(MANUFACTURING ESTABLISHMENT FE! NO. j f. Fascia X X I X X I

c. TESTING FOR MICRO-ORGANISMS ONLY I

; . g. Heart Valve i I 5. ENTER CORRECTIONS TO lll:M 4 I

' I I l h. Ugament X X X X

0 SIP 6. MAILING ADDRESS OF REPORTING OFFICIAL (Include institution name ~applicable, i. Oocyte 0 Directed number and street, city, state, country, and post office code) 0 Anonymous -RT[ Biologics, Inc.

j. Pericardium X X X X Attn: Cheryl L Bagwell, CTBS

li 621 Research Circle k.. Peripheral 0 Autologous

I I Alachua, Florida 326!5 Blood Stem 0 Family Related I 0 Allogeneic I i

L Sclera I I 0SIP I '

a_ PHONE 386-418-8888 EXT 4564 m.Semen 8 Directed 7. ENTER CORRECTIONS TO ITEM 6 Anorwmous

b. PHONE n. Skin X X X X

I o. Somatic Ceil 0 Autologous I Therapy RFamily Related I Products Allooeneic I

8. U.S. AGENT Cheryl L. Bagwell, CTBS P- Tendon X X I X X RTI Biologics, Inc.

q. Umbilical b! Atrtologous l

I I 11621 Research Circle, Alachua, Florida32615 Cord Blood 0 Family Related I 0AIIogeneic l

a. E-MAIL [email protected] 386-418-8888-4564 r. Vascular Graft I i I 1

I I l ! I 9. REPORTING OFFICIAL'S SIGNATURE S.

I i t. I I

a. lYPED NAME Cheryl L Bagwell, CTBS i ! b. E'MAIL [email protected]

u.

i c. TITLE Compliance Manager d. DATE 28-NOV-2011 v.

I ;

FORM FDA 3356 (11111)


FOOD AND DRUG ADMINISTRATION ESTABLISHMENT REGISTRATION AND LISTING FOR HUMAN CELlS, TISSUES,

AND CElLUlAR AND TISSUE-BASED PRODUCTS (HCT/Ps) (See reverse side for instructions)



subsidiary ofRTI Biologics, Inc. in Alachua, Florida location. This letter allows Karl Koschatzky, President of Tutogen Medical, GmbH, in NeUILlcirchen, Germany to register the Ukraine recovery sites with the FDA. Please contact Cheryl Bagwell for a copy if necessary.

Tutogen Medical, Inc. a wholly owned subsidiary ofRTI Biologics, Inc.


FORM FDA3356 (11/11)

1. REGISTRATION NUMBER (FDA E~ablishment Identifier)

FEI: 3007014617

See tr.st-ud:ionsforOMB Statement FORM APPROVED: OMB No. 0910-0543. Expiration Date: 1!31/14

2 lj

I

'I

Page:2

Set: lns1ructions for OMB State'llent FORM APPROVED: OMB No. 091D-<J543. Expiration Date: 1131114

DEPARTMENT OF HEALTH AND HUMAN SERVICES I. REGISTRATION NUMBER I 2. REASON FOR SUBMISSION VAliDATION-FOR FDA USE ONLY 1

PUBLIC HEALTH SERVICE (FDA ES1ablisrun~nt Identifier) a. 0 INITIAL REGISTRATION I liSTING VALIDA TED BY FDI\:29-NOV-2011 FOOD AND DRUG ADMINISTRATION I DISTRICT: lnt'l Operations Group i b. {XJ ANNUAL REGISTRATION /liSTING

ESTABLISHMENT REGISTRATION AND LISTING FOR HUMAN CELLS, TISSUES, FE!: 3007014647 I c. D CHANGE IN INFORMATION PRINTED BY FDA:27-JUL-2D12

AND CELLULAR AND TISSUE-BASED PRODUCTS {HCT/Ps) (See reverse side for instructions) d. n INACTIVE ·---·---

PART 1- ESTABLISHMENT INFORMATION i PART II -PRODUCT INFORMATION no : 3:::tl jji~-~ .,m : rnm i ""' i 52~ 3. OTHER FDA REGISTRATIONS i10. ESTABLISHMENT FUNCTIONS AND TYPES OF HCT IPs -" oC'lC:(") ~~ ~s I ~~s~ a. BLOOD FDA 2830 NO. 'I

Establishment Functions -a> 14. PROPRIETARY :.m em NAME(S) oC I >~"'·

Package l Procf!:ss l StorQ

mo .... 0 Types of HCT I Ps z S> 0 >

b. DEVICES FDA 2891 NO. R•~ver Screen Te:.1 1...3bel Distribute ~ ~CA ~ "'

I c:

" c. DRUG FDA 2656 NO. I"'

; 4. PHYSICAL LOCATION (lndude legal name, number and street, city, state, country, and

a. Bone X I X I ! i X X I post office code) i I

Chernigov Regional FM Bureau (CVl) b. Cartilage X

I X

! X X

Pirogov Street, 18 c. Comea i Chemigov, 14005 Ukraiue d. Dura Mater

OstP

I I

I I e. Embryo 0 Directed I a. PHONE 49913499880 EXT 0 Anon\lrnous

b.Q SATELLITE RECOVERY ESTABLISHMENT f. Fascia X X X I X

D(MANUFACTURING ESTABLISHMENT FEI NO. c. TESTING FOR MICRO-ORGANISMS ONLY

I I 5. ENTER CORRECTIONS TO ITEM 4

g. Heart Valve I I

h. Ligament X X I X X

0SIP

I 6. MAIUNG ADDRE;SS OF REPORTING OFFICIAL (Include institution name if applicable. i. Oocyte 0 Directed number and stree~ city, state. oountry, and post office code) 0 Anonymous

RTI Biologics, Inc. X X ;

Attn: Cheryl L. Ba,owell, CTBS j. Pericardium i X X

! ll621 Research Circle k. Peripheral Q Autologous i Alachua, Florida 32615 Blood Stem 0 Famijy Related I 0AIIogeneic

I I. Sctera

OSIP

I I

a. PHONE; 386-418-8888 EXT4564 m.Semen 0 Directed I 7. ENTER CORRECTIONS TO ITEM 6 FlAnonvmous

b. PHONE n. Skm X X X X ! I I a. Somatic Cell 0 Autologous

I Therapy R,Family Related I Products AllaoEmeic I ,

8. U.S. AGENT Cheryl L. Bagwell, CTBS p. Tendon X --

X X X RTI Biologics, Inc. 11621 Research Circle, Alachua, Florida 32615

q. Umbilical W Autologous Cord Blood 0 Family Related

0 Allogeneic ·-

a. E-MAIL [email protected] 386-418-8888-4564 r. vascular Graft i

9. REPORTING OFFICIAL'S SIGNATURE I S. ! .. , I I.

I i a. TYPED NAME Cheryl L. Bagwell, CTBS ! b. E-MAIL [email protected]

u.

i i I c. TITLE Compliance Manager d. DATE 28-NOV-2011 v. I i I I l - I I I FORM FDA 3356 (11111)



AND CELLULAR AND TISSUE-BASED PRODUCTS (HCT/Ps) (See reverse side for ir\Structlons)

ADDITIONAL INFORMATION'

Authorization Letter from Ministry of Health ofUkraine Bioimplant is on file at Tutogen Medical, Inc. a wholly owned

subsidiary of RTI Biologics, Inc. in Alachua, Florida location. This letter allows Karl Koschatzky, President ofTutogen Medical, GmbH, in Neunkirchen, Germany to register the Ukraine recovery sites with the FDA. Please contact Cheryl Bagwell for a copy if necessary.

Tutogen Medical, Inc. a wholly owned subsidiary ofRT! Biologics, Inc.


FORM FDA 3356 (11/11)

1. REGISTRATION NUMBER {FDA Es1ab!ishment klentifLer)

FEI: 30070!4647

see Instructions tor OMB Statement FORM APPROVED: OMB No. 0910-0543. Expiration Date: 1/31/14 2

Page:2

See Instructions for OMS Statement FORM APPROVED: OMB No. 0910-0543. Expiration Date: 1131114

DEPARTMENT OF HEALTH AND HUMAN SERVICES 1. REGISTRATION NUMBER i 2. REASON FOR SUBMISSION VALIDATION-FOR FDA USE ONLY t

PUBLIC HEALTH SERVICE (FDA Establishment Identifier) i a. 0 INITIAL REGISTRATION I LISTING VALIDATED BY FDA:29-NOV-2011 FOOD AND DRUG ADMINISTRATION b. 00 ANNUAL REGISTRATION I LISTING DISTRICT: lnl1 Opera:ions Group

ESTABLISHMENT REGISTRATION AND LISTING FOR HUMAN CELLS, TISSUES, FEI: 3007015435 PRINTED BY FDA:27-JUL-2012

AND CELLULAR AND TISSUE-BASED PRODUCTS (HCT/Ps) c._ R CHANGE IN INFORMA noN (See reverse side for instruc'"Jons} d. INACTTv<=

PART 1- ESTABLISHMENT INFORMATION PART II -PRODUCT INFORMATION oe~~ I ~:~:~ ....... , co:::u-

3. OlliER FDA REGISTRATIONS 10. ESTABLISHMENT FUNCTIONS AND TYPES OF HCT IPs :B~x f!i~;; ~~~; E~~ ~~~ g~~~

a. BLOOD FDA 2830 NO. Establishment Functions I ~~=t:i r--4:u oo~=t:i 14. PROPRIETARY ' <5~"' ~011t ~;;tl~q! NAME(S)

i Types of HCT IPs z: :S:P 0 >

b. DEVICES FDA 2891 NO. Recover s~n Tnst :Package Prooess Storo Label DistrlbUto ~ ~"' ~ r:.n

~ "' I "'


.4. PHYSICAL LOCATlON (\ndude legal name. number and street, city, state, counny, and a. Bone X X X i

X post office code) I

Dnepropetrovsk Regional FM Bureau (DNl) I I

X b. Cartilage X X X I

Oktyabrskaya Square-14 I ' c. Cornea

Dnepropetrovsk. 49005 I Ulcraine d. Dura Mater I I I

1 Os!P ! e. Embryo 0 Directed

a. PHONE 49913499880 EXT 0 Anonvmous i I b.o SATEWlE RECOVERY ESTABLISHMENT f. Fascia I X X r X X !

1 D(MANUFACTURING ESTABLISHMENT FE! NO. I c. lESTING FOR MICRO..ORGANISMS ONLY I I g. Heart Valve I

I 5. ENTER CORRECTIONS TO ITEM 4 I

h. Ligament X X X X I OSIP I

6. MAIUNG ADDRESS OF REPORTING OFFICIAL {Include institufion name if applicoble. i. Oocyte 0 Directed I number and street. city, state, country, and post office code) 0 Anonymous I

RTI Biologics, Inc. j. Pencardium X X X X

Attn: Cheryl L. Bagwell, CTBS 11621 Research Circle k. Peripheral 0 Autologous ' Alachua, Florida 32615 Blood S:em 0 Family Related

0 Allogeneic

!.Sclera I I

OSIP I I a. PHONE 386-418-8888 EXT 4564 m.Semen 0 Directed

7. ENTER CORRECTIONS TO ITEM 6 nAnonvmous b. PHONE

i I n. SKin X X X I X I I I

o. Somatic Cell CAutologous

I Therapy R;amily Related I I Products A~l-~eneic I

8. U.S. AGENT Cheryl L. Bagwell, CTBS ' I p.lendon X X X X RTI Biologics, Inc.

11621 Research Circle, Alachua, FloridA 32615 q. Umbilical g Autologous

Corti Blood 0 Family Related 0Aifogeneic

a. E-MAIL [email protected] 386-418-8888-4564 r. Vascular Graft I 9. REPORTING OFFICIAL'S SIGNATURE s.

t I a. TYPED NAME Cheryl L Bagwell, CTBS

b. E-MAIL [email protected] u. I i i

c. TITLE Compliance Manager d. DATE 28-NOV-201! v. ;

I I I

FORM FDA3356 (11/11}



AND CELLULAR AND TISSUE-BASED PRODUCTS (HCTIPs) (See reverse side for instruc'Jons}

ADDITIONAL INFORMATION;

Authorization Letter from Ministry of Health ofulaaine Bioimplant is on file at Tutogen Medical, Inc. a wholly owned

subsidiary ofRTI Biologics, Inc. in Alachua, Florida location. This letter allows Karl Koschatzk:y, President ofTutogen Medical, GmbH, in Neunldrchen, Germany to register the Ukraine recovery sites with the FDA. Please contact Cheryl Bagwell for a copy if necessary.

Tutogen Medical, Inc. a wholly owned subsidiary ofRTl Biologics, Inc.

Proprietary Name(s}:

FORM FDA3356 (11111)

1. REGISTRATION NUMBER (FDA Est:abltshment lde11tifier)

FEI: 3007015435

See lr-.strue1ions for OMB Statement FORM APPROVED: OMB No. 0910-0543. Expiration Date: 1/31/14

Page:2

See Instructions for OMS Sl1l1emcnt FORM APPROVED: OMS No. 0910-0543. Expiration Date: 1/31/14

DEPARTMENT OF HEALTH AND HUMAN SERVICES 1. REGISTRATION NUMBER I 2. REASON FOR SUBMISSION VALIDATION-FOR FDA USE ONLY 1

PUBLIC HEALTH SERVICE {FDA Establishment Identifier) a. 0 INITIAL REGISTRATION I LISTING VALIDATED BY FDA:29-NOV-2011 FOOD AND DRUG ADMINISTRATION b. 00 ANNUAL REGISTRATION I LISTING DISTRICT: lnt1 Operations Group

ESTABLISHMENT REGISTRATION AND LISTING FOR HUMAN CELLS, TISSUES, FEI: 3007015549 i c. 0 CHANGE IN INFORMATION PRINTED BY FDA:27-JUL-2012

AND CELLULAR AND TISSUE-BASED PRODUCTS (HCT/Ps) (See reverse slde for instructions) ! d.o INACTIVE '

PART I -ESTABLISHMENT INFORMATION PART II- PRODUCT INFORMATION ~rn~! ~~; ~~~ I 3. OTHER FDA REGISTRATIONS 10. ESTABLISHMENT FUNCTIONS AND TYPES OF HCT IPs E~2! ~~~ g~~ I I 14. PROPRIETARY a. BLOOD FDA 2830 NO. Establishment Functions ::~~ ~~:: ~~nl NAME(S) I

0 _ rno .- o

b. DEVICES FDA 2891 NO. i Types of HCT I Ps R6t;OYor Sc~n T"" Pacb:lgo PI'OCQSS Stcrre Label Distribute ~ ~~ l ~ ~

(/) : 0 I.,


4. PHYSICAL LOCATION (Include legal name, number and street, city, state, country, and a. Bane X X X X

past office code)

Donetzk Regional Forensic Medical Bureau (DON1) b. Cartilage X X X X

Prospect Iliiicha 14 i ' c.Comea Block No.9 I

Donetzk. 83099 d. Dura Mater I I L'kraine I

Os1P e. Embryo 0 Directed

a. PHONE 49913499880 EXT 0 Anonymous I b. 0 SATELLITE RECOVERY ESTABLISHMENT

f. Fascia X X I X X t D(MANUFACTURING ESTABLISHMENT FEI NO. ! c. TESTING FOR MICRO-oRGANISMS ONLY

! I I 5. ENTER CORRECTIONS TO ITEM 4

g. Heart Valve I

I

h. Ligament X X X i X I ' 0 SIP

I i 6. MAILING ADDRESS OF REPORTING OFFICIAL (lncl"de instit"tion name if applicable, i. Oocyte 0 Directed 1 number and street. city. state, count')', and post office code) 0 Anonymous I RTI Biologics, Inc.

j. Pericardium X X I X X ' 1 Attn: Cheryl L. Bagwell, CTBS I 11621 Research Circle k. Peripheral b! Autologous

Alachua, Florida 32615 Blood Stem 0 Family Related DAHogeneic

I. Sclera I I !

\ m. Semen OSIP

I I a. PHONE 386-418-8888 EXT4564 B Directed 7. ENTER CORRECllONS TO ITEM 6 Anonymous

b. PHONE n. Skin X X X X

I o. Somatic Cell 0 Autologous i Therapy 8 Family Related

Products Allogeneic I I

8. U.S. AGENT Cheryl L. Bagwell, CTBS P- Tendon X X X I I X

RTI Biologics, Inc. ! i 11621 Research Circle, Alachua, Florida 32615

q. Umbilical !=!Autologous I

I Cord Blood 0 Family Related I

0 Allogeneic


, 9. REPORTING OFFICIAL'S SIGNATURE s. I I

i I. I ! I a. TYPED NAME Cheryl L. Bagwell, CTBS I i I I b. E-MAIL [email protected]

u. l I I , c. TITLE Compliance Manager d. DATE 28-NOV-2011 V.

I ! I I I I : FORM FDA 3356 (11/11)

1.. DEPARTMENT OF HEALTH AND HUMAN SERVICES

PUBLIC HEALTH SERVICE , FOOD AND DRUG ADMINISTRATION

ESTABLISHMENT REGISTRATION AND LISTING FOR HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS (HCT/Ps)

{See reverse skie for instructions)


Authorization Letter from Ministry of Health of Ukraine Bioimplant is on fJ]e at Tutogen Medical, Inc. a wholly owned subsidiary of RTI Biologics, fuc. in Alachua, Florida location. This letter allows Karl Koschatzky, President ofTutogeo Medical, GmbH, in Neunkirchen, Gerrnwy to register the lJk:nrine recovery sites with the FDA. Please contact Cheryl Bagwell for a copy if necessary.

Tutogen Medical, Inc. a wholly owned subsidiary of RTI Biologics, hie.


FORM FDA3356 (11/11)


FE!: 3007015549

See JnstructionsforOMB Statement FORM APPROVED: OMB No. 0910-0543. Expiration Date: 1131/14

Page:2

See Instructions for OMS Statement FORM APPROVED: OMB No. 0910-0543. Expiration Date: 1131114

DEPARTMENT OF HEALTH AND HUMAN SERVICES 1. REGISTRATION NUMBER 1 2. REASON FOR SUBMISSION VALIDATION-FOR FDA USE ONLY , PUBLIC HEALTH SERVICE {FDA Establishment kleni.Hicr) a. 0 INITIAL REGISTRATION I LISTING VALIDATED ~y FDA:29-NOV-2011

FOOD AND DRUG ADMINISTRATION : b. 00 ANNUAL REGISTRATION I LISTING ~~~;~~t~g~;~~~~~-;~~~p ESTABLISHMENT REGISTRATION AND LISTING FOR HUMAN CELLS, TISSUES, FEI: 3007015909

i AND CELLULAR AND TISSUE-BASED PRODUCTS (HCT/Ps) I C .. R· CHANGE IN INFORMATION

(See reverse side for inslruct'ons) ! d. , INACTIVE i

PART I -ESTABLISHMENT INFORMATION PART ll- PRODUCT INFORMATION no ""'~ a:l0:13"""

~m mm!'=l o:cm~

"'"' ""'"' ,.t:G'l:t 13- OlllER FDA REGISTRATIONS 10. ESTABLISHMENT FUNCTIONS AND TYPES OF HCT IPs ~a ..,, oc:o a COle:()

::m >\:::! QU)f"'"-i 14. PROPRIETARY

a. BLOOD FDA 2830 NO. Establishment Functions :..m r_,-, ~~~~ om• NAME(S)

Test [Pookago oO mo r o

Types of HCT IPs z "'" 0 1:;

I b. DEVICES FDA 2B91 NO. Recover Seven Procass Store t..abel Distribute ~ "" " m c I"' ~

c. DRUG FDA 2656 NO. I I 4. PHYSICAL LOCATION (Include legal name, number and street, city, state, country, .and

a. Bone I X X I

X X I i post offire code) I

Lugansk Regional FM Bureau (LUG3) b. Cartilage X X X I X

Block of 50 Year Lul!ansk Defense-- 14 I i ' ! c. Cornea

Lugansk, 91045 ' 'lJk:raine i d. Dur.a Ma1er I

I I

I OSIP i i I e. Embryo 0 D~ec1ed ' a.PHONE 49913499880 EXr 0 Anonvmous I

--~

b.Q SATELLITE RECOVERY ESTABLISHMENT

I i ! o(MANUFACTURING ESTABLISHMENT FEI NO. f. Fascia X X X i

X '

c. TESTING t=OR MICRO-ORGANISMS ONLY I

I ! 5. ENTER CORRECTIONS TO ITEM 4

g. Heart Valve I I

h. Ligament X X X ! X --~-

0 SIP 5_ MAILING ADDRESS OF REPORTING OFFICIAL (Include institution name if applicable, LOocyle D Directed I number and street. city, state, country, and post office code} D Anonymous '

RTI Biologics, Inc. j. Pericardium

Attn: Cheryl L. Bagwell, CTBS X X I I X X

11621 Research Circle k. Peripheral 0 Autologous ! Alachua, Florida 3 2615 Blood Stem D Family Related

0AIIogeneic

1. Sclera !

OSIP I I a. PHONE386-418-8888 EXT 4564 m.Semen R Direc1ed 7. ENTER CORRECTIONS TO ITEM 6

Anonvmous b. PHONE

n. Skin X X X X ..

o. Somatic Cell D Autologous I

Therapy J:l 1

Family Related I I Products Alloqeneic

8. U.S. AGENT Cheryl L. Bagwell, CTBS p. Tendon X X X X RTI Biologics, Inc.

11621 Research Circle, Alachua, Florida 32615 q. Umbilical bJ Autologous

\

Cord Blood D Family Related I 0AIIogeneic

a. E-MAIL [email protected] 386-418-8888-4564 r. Vascular Graft I i 9. REPORTING OFFICIAL'S SIGNATURE s.

I I. I I a. TYPED NAME Cheryl L. Bagwell, CTBS !

b. E-MAIL [email protected] u. i I I I I I I I

1 c. TITLE Compliance Manager d. DATE 28-NOV-2011 v. J I

1 l i ; ~~~- I !

FORM FDA 3356 (11/11)



AND CELLULAR AND TISSUE-BASED PRODUCTS (HCT/Ps) (See reverse side for tnstructio:-~s}


Authorization Letter from Ministry of Health of Ukraine Bioimplant is on ftle at Tutogen Medical, Inc. a wholly owned

subsidiary of RTI Biologics, Inc. in Alachua, Florida location. This letter allows Karl Koschatzky, President ofTutogen Medical, GmbH, in Neunkirchen, Germany to register the Ukraine recovery sites v.~th the FDA. Please contact Cheryl Bagwell for a copy if necessary.

Tutogen Medical, Inc. a whoily owned subsidiary ofRTI Biologics, Inc.


1. REGIS1RA TION NUMBER {FDA Establishment Identifier)

FEI: 3007015909

See Instructions for OM3. Sta!emel)t FORM APPROVED: OMB No. 0910-0543. Expiration Da~e: 1/31/14

z I!

II

! I

I

FORM FDA 3356 (11/11) Page:2

See lnstrud.ions forOM8 State-nent FORM APPROVED: OMB No. 0910-0543. Expiration Date: 1i31114

DEPARTMENT OF HEALTH AND HUMAN SERVICES 1. REGISTRATION NUMBER 2. REASON FOR SUBMISSION VALIDATION-FOR FDA USE ONLY 1

PUBLIC HEALTH SERVICE (FDA Establishment Identifier} a. 0 INITIAL REGISTRATION I LISTING VALIDATED BY FDA:29-NOV-Z011

FOOD AND DRUG ADMINISTRATION b. 00 ANNUAL REGISTRA 110N I LISTING DIS11RICT: lnt1 Operations Group

ESTABLISHMENT REGISTRATION AND liSTING FOR HUMAN CELLS, TISSUES, FEI: 3007015955 PRINTED BY FDA:27-JUL-2012

AND CELLULAR AND TISSUE-BASED PRODUCTS (HCT/Ps) c. 0 CHANGE IN INFORMATION

(See reverse side for instructions) d.n INACTNE

PART I- ESTABLISHMENT INFORMATION PART II -PRODUCT INFORMATION 00 i ~~;:; "'""' ~m 0~~

110. ESTABLISHMENT FUNCTIONS AND TYPES OF HCT IPs "'"' "":r 3. OTHER FDA REGISTRAllONS ~n oc:o bg~ ~"' :»~::! Estabflshment Functions

:tal ~~~ 14. PROPRIETARY a. BLOOD FDA 2830 NO. :.m r.<•

oO om 0 NAME(S) I mo r o

Types of HCT IPs z ,,. 0 1;;

b. DEVICES FDA 2891 NO. RocoVQr Scr&et1 T•:st Padc.age Proooss Store Label I D;stlibuto ~ ""' "' ~ c:

I ~ c. DRUG FDA 2656 NO.

I 4~ PHYSICAL LOCATION (Include legal name. number and street, city, state, country, and

a. Bone post office code)

X X X I X i Kiev City Forensic Medie<U Bureau (KV3) X X 1

I X \ X I b. Cartilage \

Petra Zaporozhtsa Street-26

c. Cornea i I I I Kiev, 04125 d. Dura Mater I i Ulcraine

Os1P

I I e_ Embryo 0 Directed a. PHONE 49913499880 EXT 0 Anonvmous i b.o SATEWTERECOVERY ESTABLISHMENT

t FC!scia X X X X I D{MANUFACTURING ESTABUSHMENT FEI NO. c. TESllNG FOR MICRO-ORGANISMS ONLY

5. ENTER CORRECTIONS TO ITEM 4 g. Heart Valve l :

h. Ugament X X X X I

0 SIP 6. MAIUNG ADDRESS OF REPORTING OFFICIAL (Include institution name if appl'iCable. i.Oocyte 0 Directed

number and street, city, state. country, and post office code) 0 Anonymous

RTI Biologics, Inc. j. Pericardium X I X X X

Attn: Cheryl L. Bagwell, CTBS I

11621 Research Circle j k. Peripheral 0 Autologous I I Alachua, Florida 32615 1 Blood Stem D Family Related ! 0 Allogeneic

I ! I. Sclera I

0SIP i I a. PHONE 386-418-8888 EXT 4564 m. Semen 0 Dkected -- 0Anonvmous I

7. ENTER CORRECTIONS TO ITEM 6 ' I b. PHONE

I I n.Skin X X X X

a. Somatic Cell 0 Autologous

\

i Therapy R Family Related Products Allooeneic

8. U.S. AGENT Cheryl L. Bagwell, CTBS p. Tendon X X I X X I RTI Biologics, Inc.

11621 Research Circle, Alachua, Florida 32615 q. Umbilical b! Aulologous

Ccrd Blood 0 Family Related 0 Allogeneic

a. 2-MAIL [email protected] 386-418-8888-4564 r. Vascular Graft

9. REPORllNG OFFICIAL'S SIGNATURE s. \

t_ I a. TYPED NAME Cheryl L. Bagwell, CTBS

b. E-MAIL [email protected] U.

I c. T:TLE Compliance Manager d. DATE 28-NOV-2011 v_

I I !

FORM FDA 3356 (11/11)


FOOD AND DRUG ADMINISTRATION ESTABLISHMENT REGISTRATION AND LISTING FOR HUMAN CEllS, TISSUES,

AND CEllULAR AND TISSUE-BASED PRODUCTS (HCT/Ps) (See reverse side for ir1structions)


Authorization Letter from Ministry of Health of Ukraine Bioimplant is on file at Tutogen Medical, Inc. a wholly owned subsidiary of RTI Biologics, Inc. in Alachua, Florida location. This letter allows Karl Koschatzky, President ofTutogen Medical, GmbH, in Nennkirchen, Germany to register the Ukraine recovery sites with the FDA. Please contact Cheryl Bagwell for a copy if necessary.

Tutogen Medica~ Inc. a wholly owned subsidiary ofRT[ Biologics, Inc.


FORM FDA 3356 (11/11}

1. REGISTRATION NUMBER (FDA Establishment !den1ifier}

FEI: 3007015955

~ lnstructiofl:;forOM6S:<~otement FORM APPROVED: OMS No. 0910-0543. Expiration Date: 1/31/14

Page:2

See lnstructio11s for OMB Stalement FORM APPROVED: OMB No. 0!?10-0543. Expiration Date: 1/31/14

DEPARTMENT OF HEALTH AND HUMAN SERVICES 1. REGISTRATION NUMBER 2. REASON FOR SUBMISSION VALIDATION FOR FDA USE ONLY 1

PUBLIC HEALTH SERVICE (FDA Establishment Identifier) a. 0 INITIAL REGISTRATION I LISTING VALIDATED BY FDA:29-NOV-2011

FOOD AND DRUG ADMINISTRATION b. [iJ ANNUAL REGISTRATION I LISTING DISTRICT: lnt'l Operations Group ESTABLISHMENT REGISTRATION AND LISTING FOR HUMAN CELLS, TISSUES, FE!: 3007016029 PRINTED BY FOA:27-JUL-2012

AND CELLULAR AND TISSUE-BASED PRODUCTS (HCT!Ps} c. 0 CHANGE IN INFORMATlON

(See reverse side for instructions} d. Fi INACTlVE

PART I- ESTABLISHMENT INFORMATION PART II- PRODUCT INFORMATION oc- ,.,- OJO:JJ....L ..,m:"" mm!'l O?:~tn~ ""':x: 5@~ ,c:(;):r

3. OTHER FDA REGISTRAllONS 10. ESTABLISHMENT FUNCTIONS AND TYPES OF HCT IPs §~~ ~~~~ Establishment Functions ~E=i1 14. PROPRIETARY a. BLOOD FDA 2830 NO. :..mw om"· ~;g~~ NAME(S)

Sc;reen ! Test

I oc

~c Types of HCT IPs = _,

0 1;; b. DEVICES FDA 2891 NO. Rocovor PKkage. Proct"s:s Store Lab< I Distribute w '"' " I::: <:

I :;)

' c. DRUG FDA2656 NO. ! ! !

4. PHYSICAL LOCATION (Include legal name, number and street, city, state. country, and ! a. Bone X X X X I

posl office code) I

Kherson Regional Forensic Medical Bureau (KHE 1) I l I

b. Cartilage X X I X X

Starostina Street- 17 ; ! I ! I I I i c. Cornea I Kherson. 73024 Ukraine d. Dura Mater

Os1P e. Embryo 0 Directed

a. PHONE 49913499880 EXT 0 Anonymous i b.Q SATELLITE RECOVERY ESTABLISHMENT

!

I f. Fascia X X X X , D(MANUFACTlJRING ESTABLISHMENT FEI NO. I c. TESTING FOR MICRO-ORGANISMS ONLY

5, ENTER CORRECTIONS TO ITEM 4 g. Heart Valve

h. Ligament X X I X X

0 SIP I 6. MAILING ADDRESS OF REPORTING OFFICIAL (Include inslitution name if applicable, i. Oocyte 0 Directed number and stre--et, city, state, country, and post office code) 0 Anonymous I

!

RTI Biologics, Iuc. j. Pericardium X X X X

Attn: Cheryl L. Bagwell, CTBS 11621 Research Circle K. Peripheral 0 Autologous

i Alachua, Florida 32615 Blood Stem 0 Family Related 0Allogeneic I

!.Sclera I I 0SIP I I

I a. PHONE 386-418-8888 EXT4564 m. Semen 0Dinected I 1 7. ENTER CDRRECllONS TO ITEM 6 Fi Anonymous b. PHONE --

n. Skin X ! X X X i

o. Soma~c Cell 0 Autologous-·--·

I I Therapy R 1

Family Related Products AlloQeneic

8. U.S. AGENT Cheryl L. Bagwell, ClBS p. Tendon X X X X I I RTI Biologics, Iuc.

I 1162! Research Circle, Alachua, Florida 32615

q. Umbilical bd Autologous

I I Cord Blood 0 Family Related I

0AIIogeneic

a. E-MAIL [email protected] 386-418-8888-4564 r. Vascular Graft I 9. REPORTING OFFICIAL'S SIGNATURE s.

I I I t. !

l I i a. TYPED NAME Cheryl L. Bagwell, ClBS I

b. E-MAIL [email protected] u. I I

c. TI1LE Compliance Manager d. DATE 28-NOV-2011 v.

I I

I I FORM FDA 3356 {11111)

DEPARTMENT OF HEALTH At-ID HUMAN SERVICES PUBLIC HEALTH SERVICE

FOOD AND DRUG ADMINISmATJON ESTABLISHMENT REGISTRATION AND LISTING FOR HUMAN CELLS, TISSUES,



Authorization Letter from Ministry of Health of Ukraine Bioimplant is on file at Tutogen Medical. Inc. a wholly owned

subsidiary ofRTI Biologics, Inc. in Alachua, Florida location. lbis letter allows Karl Koschatzky, President ofTutogen Medical, GmbH, in N eunkirchen, Germany to register the Ukraine recovery sites with the FDA. Please contact Cheryl BagweU for a copy if necessary.

Tutogeo Medica~ Inc. a wholly owned subsidiary ofRTI Biologics, Inc.


FORM FDA 3356 (11{11)


FEI: 30070 !6029

See 1nstrudionsfo~ OMB Statemenl FORM APPROVED: OMS No. 0910-0543. Expiration Date: 1/31/14

Page:2

See Instructions for OMS Statement FORM APPROVED: 0\.lB No. 0910-0543. Expiration Date: 1/31/14

I DEPARTMENT OF HEALTH AND HUMAN SERVICES 1. REGISTRATION NUMBER 2. REASON FOR SUBMISSION I VALIDATION FOR FDA USE ONLY 1

PUBLIC HEALTH SERVICE (FDA Establishment klentifier) a. 0 INITIAL REGISTRATION I LISTING VALIDATED BY FDA:29-NOV-2011 FOOD AND DRUG ADMINIS1RATION b.~ ANNUAL REGISTRATION I LISTING DISTRICT: lnt'l Operations Group

ESTABLISHMENT REGISTRATION AND LISTING FOR HUMAN CELLS, TISSUES, FEI: 3007016069 PRINTED BY FDA:27-JUL-2012 AND CELLULAR AND TISSUE-BASED PRODUCTS (HCT/Ps) c. D CHANGE IN INFORMATION

(See reverse side for instruct;ons) d. D INACTIVE

PART I- ESTABLISHMENT INFORMATION I PART 11- PRODUCT INFORMATION 00 ;::o- ""'"' I

~m mrn~ 0~§ l10. ESTABLISHMENT FUNCTIONS AND TYPES OF HCT IPs "'"' ""'"' 3, 01HER FDA REGISTRAllONS -" c;c:o bfJ~ N;o >I:'" !

Establishment Functions :::Oj ~g~ 14. PROPRIETARY

a. BLOOD FDA 2830 NO. :..m r...,-c om• NAME(S)

Label I m.tnbut•

cO me r o

j Types of HCT I Ps z ~~ 0 ~

I b. DEVICES FDA2891 NO. Re~covor

·~· Tost Package Proccs:; SioN N "'

Jrn " l g

c. DRUG FDA 2656 NO. i I

.4. PHYSICAl LOCATION (Include legal name, number and street, city, state, country. and a. Bone X X I X i X

post ofke code) I Kharkov Regional FM Bureau (KH3)

b. Cartilage X X X I X

Korcha,gintzev Street 35 c. Cornea i

Kharkov, 61176 Ukraine i

d. Dura Mater ! OsiP

I i

e. Embryo 0 Directed I a. PHONE 49913499880 EXT 0Anonymous b.o SA1ELLillE RECOVERY ESTABLISHMENT

f. Fascia X X X X -(MANUFACTURING ESTABLISHMEN1 FEI NO. c. U llESTING FOR MICRO-ORGANISMS ONLY

I I -

5. ENTER CORRECTIONS 10 ITEM 4 g. Hearr.Vatve

I I h. Ligament X X X I X

I 0 SIP i

6. MAILING ADDRESS OF REPORTING OFFICIAL (Include institution name if applicable, i.Oocyte 0 Directed I I number and street, dly, state, country, and post office code) 0 Anonymous I

RTI Biologics, Inc. j. Pericardium X

Attn: Cheryl L. Bagwell, CTBS X X X

11621 Research Circle k. Peripheral ~Autologous

Alachua, Florida 32615 Blood Stem 0 Family Related 0AIIogenelc

1. Sclera

OS.IP

I I I

a. PHONE 386-418-8888 EXT4564 m. Semen 0 Directe<! I 7. ENTER CORRECTIONS TO ITEM 6 0Anonvmous

b. PHONE X X I n.Skin I X X

! l o. Somatic Cell 0 Autologous I i I I

Tnerapy R,Family Related I

i Products AUog_eneic


11621 Research Circle, Alachua, Florida 32615 q. Umbilical bJ Autologous

I Cord Blood 0 Family Related

0Ailogeneic


9. REPORllNG OFFICIAL'S SIGNATURE s. I

t i I

I ' I a. TYPED NAME Cheryl L B""'owe!l, CTBS I u.

I I I I

1 b. E-MAIL [email protected] I I i i c. TITLE Compliance Manager d. DATE 28-NOV-2011 v. I

I

I I I - I FORM FDA3356 (11/11)





Authorization Letter from Ministry of Health of Ukraine Bioimplant is on file at Tutogen Medical, Inc. a wholly ovvned

subsidiary of RTI Biologics, Inc. in Alachua, Florida location. This letter allows Karl Koschatzky, President ofTutogen Medical, GmbH, in Neunkirchen, Germany to register the Ukraine recovery sites with the FDA. Please contact Cheryl Bagwell for a copy if necessary.



FORM FDA3356 (11/11)

1. REGISTRATION NUMBER (FDA Establishment ldenlffier)

FB: 3007016069

Sec lnslruclions for DMB Sta1ement FORM APPROVED: OMB No. 0910-0543. Expiration Date: 1/31114

Page:2

See l~s1ructions for OMB Statement FORM APPROVED: OMB No. 0910.{)543. Expiration Date: 1131/14

DEPARTMENT OF HEALTH AND HUMAN SERVICES 1. REGISTRATION NUMBER 2. REASON FOR SUBMISSION VALIDATION-FOR FDA USE ONLY 1 l PUBLIC HEALTH SERVICE (FDA Estab!ishmer.t Identifier) a. 0 INITIAL REGISTRATION I LISTING VALIDATED BY FDA:2!l-NOV-201 1

I FOOD AND DRUG ADMINISTRATION b 00 ANNUAL REGISTRATION f LISTING DISTRICT: lnt'l Operations Group ESTABLISHMENT REGISTRATION AND LISTING FOR HUMAN CELLS, TISSUES, FE!: 30070!6090 c: D CHANGE IN INFORMATION PRINTED BY FDA:27-JUL-2012 I

AND CELLULAR AND TISSUE-BASED PRODUCTS (HCT/Ps)

--1 (See reYerse side for instructions) d.CJ INACTIVE '

PART 1- ESTABLISHMENT INFORMATION I PART II -PRODUCT INFORMATION ) no- ~~~! 6~~~ 3. OTHER FDA REGISTRATIONS 110. ESTABLISHMENT FUNCTIONS AND TYPES OF HCT IPs l ~~~ ~g~ i b~@~

>~::!I QU)~::! ' ~~~ 14. PROPRIETARY

I I a. BLOOD FDA 2830 NO. Establishment Functions ~g:w ~til~ ~g~~ NAME(S)

i mo r o Types of HCT I Ps I z :S)Io 0 ::t>-

b. DEVICES FDA 2891 NO. Recover ScrMn ! Test I Pockage Proooss Sto,. U.bel Oistilbuto !::: 0(1) :;:o OJ

::; c ~

c. DRUG FDA 2656 NO. I I I

4. PHYSICAL LOCATION (Include legal name, number and streel city, state, country, and I X a. Bone X X I X

post office code) I

Zhitomir Regional FM Bureau (ZHl) b. Cartilage X X X X

Post Office Guiva c. Cornea Zhitomir Region

Zhitomir. 10002 d. Dura Mater I Ukraine DSIP

e. Embryo D Directed ! a. PHONE 49913499880 EXT D Anonvmous

b.o SATELLITE RECOVERY ESTABLISHMENT f. Fascia X X X X D(MANUFACTURING ESTABLISHMENT FE! NO.

c. TESTING FOR MICRO-ORGANISMS ONLY l I 5. ENTER CORRECTIONS TO ITEM 4

g. Heart Valve '

h. Ligament X X X I

X

OSIP 6. MAILING ADDRESS OF REPORTING OFFICIAL (Include instiluUon name if applicable, i. Oocyte 0 Directed number and street, city, state. country. and post office code) 0 Anonymous

RTI Biologics, Inc. j. Pericardium X X X I X I Attn: Cheryl L. Bagwell, CTBS

11621 Research Circle k. Peripheral D Autologous --Alachua, Florida 32615 Blood Stem 0 Family Related

1 I

0AIIogen~!c 1

I. Sclera I I OSIP

I I a. PHONE386-418-8888 EXT 4564 m. Semen 0 Directed

7. ENTER CORRECTIONS TO ITEM 6 []Anonymous b. PHONE

n.Skin X X X X

o. Somatic Cell 0 Autologous i ! Therapy g;amily Related I Products Allogeneic

8. U.S_ AGENT Cheryl L. Bagwell, CTBS p. Tendon X X i X X 1 RTI Biologics, Inc. l

11621 Research Circle, Alachua, Florida 32615 q. Umb~ical b:JAuto!ogous

I Cord Blood 0 Family Related 0 Allogeneic

a. E-MAIL [email protected] 386-418-8888-4564 r. Vascular Graft I 9. REPORTING OFFICIAL'S SIGNATURE s. I

t I I a. TYPED NAME Cheryl L. Ba.,crwe!l, CTBS

b. E-MAIL cbagwell@rtix_com u.

j I l

c. TITLE Compliance Manager d. DATE 28-NOV-2011 v.

I I I ' FORM FDA 3356 (11/11)





Authorization Letter from Ministry ofHealth of Ukraine Bioimplant is on file at Tutogen Medical, Inc. a wholly owned

subsidiary ofRTI Biologics, Inc. in Alachua, Florida location. This letter allows Karl Koschatzky, President ofTutogen Medical, GmbH, in Neunkirchcn, Germany to register the Ukraine recovery sites with the FDA. Please contact Cheryl Ba,owell for a copy if necessary.



FORM FDA3356 (11/11)


FE!: 3007016090 I

i

See Instructions for OMS Statement FORM APPROVED: OMS No. 0910-0543. Expiration Date: 1131/14

Page: 2

See lretructions for OMB Statement F0'1M APPROVED: OMB No. 0910.0543. Expiration Date: 1/31114

DEPARTMENT OF HEALTH AND HLJMAN SERVICES 1. REGISTRATION NUMBER 2. REASON FOR SUBMISSION ! VALIDATION-FOR FDA USE ONLY

'I PUBLIC HEALTH SERVICE (FDA Esiabtishmentldentifter) a. D INITIAL REGISTRATION I LISTING 1 VALIDATED ~Y FDA:29-NOV-2011

FOOD AND DRUG ADMINISTRATION b. 00 ANNUAL REGISTRATION 1 LISTING: DISTRICT: Inti Operations Group ESTABLISHMENT REGISTRATION AND LISTING FOR HUMAN CELLS, TISSUES, FEI: 3007016102 0 I PRINTED BY FDA:27-JUL-2012

AND CELLULAR AND TISSUE-BASED PRODUCTS (HCT/Ps) c. CHANGE IN INFORMATION I

{See reverse side for ins1n.Jctions} d. F1 INACTIVE

PART I· ESTABLISHMENT INFORMATION PART II· PRODUCT INFORMATION nc~ ,.,~

~"~il .,m:-" rnm~ QA1m.

3. OiliER FDA REGISTRATIONS 10. ESTABLISHMENT FUNCTIONS AND TYPES OF HCT IPs "'"'"' oC>:r rC:"'::r: ~no ocn oGICo ~:o ..

~E~ G)l:llr-{.

a. BLOOD FDA 2830 NO. Establishment Functions ~~l ~~~~~ 14. PROPRIETARY om• NAME(S)

I me ' ; ' Types of HCT IPs z ,,.

b. DEVICES FDA 2891 NO. Recover Screen Tost Paekage Procoss Storo Label Distribute ~ ""' ;o "' lJ: c ~

c. DRUG FDA 2656 NO. i ·-- -----4~-PHYSICAL LOCA llON (lndude legal name, number and street, city, state, country. and

a. Bone X X I X X post office rode)

Poltava Regional FM Bureau (PLI) b. CaC:ilage X X X X I

Poltava Engels Street 27a c. Cornea I I I I Poltava. 36038 I I Ukraine

I

I i i

d. Our:a Mater I ' OsiP i

e. Embryo 0 Directed \

a. PHONE 49913499880 EXT 0 Anonvmous I I I b.o SATELLITE RECOVERY ESTABLISHMENT X X X X

D(MANUFACTURING ESTABLISHMENT FEI NO. f. Fasda

c. TESTING FOR MICRO-<:>RGANISMS ONLY

5. ENTER CORRECTIONS TO f1EM 4 g. Heart Valve

h_Ligament X X X I X

D SIP 6. MAILING ADDRESS OF REPORTING OFFICIAL (lndude instib.Jtion name if applicable, i. Oocyte D Directed I number an.d street. city, state, country, and posl office code} 0 Anonymous

RTI Biologics, Inc. j. Pericardium X X i X X I

Ann: Cheryl L. Bagwell, CTBS

!l621 Research Circle k:. Peripheral 0 Autologous

I I Alachua, florida 32615 Blood Stem 0 Family Related 0AIIagenelc

I

I. Sclera

DstP

I i I

a. PHONE 386-418-8888 EXT 4564 m.Semen 0 Directed I I 7. ENTER CORRECTIONS TO ITEM 6

0Anonvmous b. PHONE : X I n_Sk.in X X X

I o. Somatic Cell DAutoi"90US

I i Therapy RFamily Related

Products Anoaeneic >

j 8. U.S. AGENT Cheryl L. Bagwell, CTBS p. Tendon X X X

I ' X RTI Biologics, Inc. I

11621 Research Circle, Alachua, Florida 32615 q. Umbilical QAutologous I i I

Cord Blood 0 Family Reta:ed I OAI!ogeneic ! I a. E-MAIL [email protected] 386-418-8888-4564 r. Vascular Graft

I I i J i

9. REPORTING OFFICIAL'S SIGNATURE s. I

\ t I

a. TYPED NAME Cheryl L. Bagwell, CTBS I b. E-MAIL [email protected]

u. I c. TITLE Compliance Manager d. DATE 28-NOV-201l v.

I l I I I

FORM FDA3356 (11/11)



AND CELLULAR AND TISSUE-BASED PRODUCTS (HCT/Ps) (See reverse side for instruc1ions)



subsidiary of RTI Biologics, Inc. in Alachua, Florida location. This letter allows Karl Koschatzky, President ofTutogen Medical, GmbH, in Neunkirchen, Germany to register the Ukraine recovery sites with the FDA Please contact Cheryl Bagwell for a copy if necessary.



FORM FOA3356 (11111)

1. REGISTRATION NUMBER {FDA Establishment Identifier)

FEI: 30070!6102

Sec Instructions for OMS StaSement FORM APPROVED: OMB No" 0910-0543. Expiration Date: 1/31/14

Page:2

.$Qe Instructions for OMB Statemen• FORM APPROVED: OMB Nc. 0910.{)543. Expiration Date: 1/31/14

! DEPARTMENT OF HEALTH AND HUMAN SERVICES 1. REGISTRATION NUMBER I 2. REASON FOR SUBMISSION VALIDATION FOR FDA USE ONLY 1

PUBLIC HEALTH SERVICE (FDA Es1ablishrt"'0nt ldentiflcr) a. D INITIAL REGISTRATlON I LISTING VALIDATED BY FDA:OS.OCT-2011

FOOD AND DRUG ADMINISTRATION

I

b. D ANNUAL REGISTRATION I LISTING DISTRICT: lnt'l Operations Group ESTABLISHMENT REGISTRATION AND LISTING FOR HUMAN CELLS, TISSUES, FEI: 3007084772 PRINTED BY FDA:27-JUL-2012

' AND CELLULAR AND TISSUE-BASED PRODUCTS (HCT/Ps) c. IX] CHANGE IN INFORMATION INACTIVE I (See reverse side for ins1ructions} d. Fxi INACTIVE

PART 1- ESTABLISHMENT INFORMATION PART II- PRODUCT INFORMATION nc~ "'"- 5g~~! -r~rn:-'" mfl'l!'l

3. OTHER FDA REGISTRATlONS 10. ESTABLISHMENT FUNCTIONS AND TYPES OF HCT IPs ""'"' c<>:r .-e:Glr

i §~~ ()Co oC>Cn

I Establishment Functions i!S~ Qtl)~:::' 14. PROPRIETARY a. BLOOD FDA 2830 NO.

<=;0--f''t) ~tltA em• :>::OmQt NAME(S)

Package l P•ocoss I Storn

mo ... 0

Types of HCT I Ps z S> I~ ~ b. DEVICES FDA 2891 NO. Recover Semon Test l.abol Distribute !: i;l"' ., '" , ..

c. DRUG fDA 2656 NO. ; !

4_ PHYSICAL LOCATION (Include legal name, number and str~t. ~ity, state, country, and a. Sane X X X X

post office code) i Lugansk City Pathology (LUG!)

b. Cartilage X i X 'I X i X

Block of 50 year Lugansk Defense- 12 !

I I I Lugaosk. 9!045 c. Cornea

Ukraine d. Dura Mater I 0SIP

e. Embryo D Directed a. PHONE 49913499880 EXT D Anonvmous

b.o SATElliTE RECOVERY ESTABLISHMENT f. Fascia X X X X

D(MANUfACTURING ESTABLISHMENT FEI NO. c. TESTlNG FOR MICRO-ORGANISMS ONLY

I I --

5. ENTER CORRECTIONS TO llEM 4 -- g. Heart Valve

h. Ugament X X X l I X I

0SIP j I I

6. MAILING ADDRESS OF REPORTING OFFICIAL (lnciude institution name rt applicable, i. Oocyte D Directed i I number and street, city, state. country, and post office code) D Anonymous

RTI Biologics, Inc. j. Pericardium X X ~ X

Attn: Cheryl L. Bagwell, CTBS I I

ll62! Research Circle k. Peripheral D Autologous

Alachua, Florida 32615 Blood Stem 0 Family Related 0 Allogeneic

I. Sclera

OSIP I I a. PHONE 386-418-8888 EXT4564 m.Semen R.Directed 7. ENTER CORRECTlONS TO ITEM 6 Ancnvmous I

b. PHONE ' n. Skin X i X X X

o. Somatic Cell 0 Autologous I Therapy M ;amily Related Products AH~eneic !

8. U.S. AGENT Cheryl L. Bagwell, CTBS p. Tendon X X I ! X X

I RTI Biologics, Inc. .L

11621 Research Circle, Alachua, Florida 32615 q. Umbilical QAutologous ! I I I Cord Blood D Family Related

i 0 Allogeneic

o. E-MAIL [email protected] 386-418-8888-4564 r. Vascular Graft [ I

9. REPORTING OFFICIAL'S SIGNAllJRE I

s.

I t. I

a. TYPED NAME Cheryl L. Bagwell, CTBS j I

U. I

l ' b. E-MAIL [email protected] I I i

c. TITLE Compliance Manager d. DATE 05-0CT-2011 v I I ) I I

FORM FDA 3356 (11/11)

See Jnstruclions for OMB Statement FORM APPROVED: OMB No. 0910.{)543. Expiration Date: 1131/14 D:PARTMENT OF HEALTH AND HUMAN SERVICES 11. REGISTRATION NUMBER I 2. REASON FOR SUBMISSION

I VALIDATION-FOR FDA USE ONLY 1 PUBLIC HEALTH SERVICE (FDA EstabliShment Identifier) a. 0 INITIAL REGISTRATION lUSTING VALIDA TED BY FDA:29-NOV-2011

FOOD AND DRUG ADMINISTRATION

I b. 00 ANNUAL REGISTRATION I LISTING DISTRICT: lnt'! Operations Group

ESTABLISHMENT REGISTRATION AND LISTJNG FOR HUMAN CELLS, TISSUES, I FEI: 3007084785 PRINTED BY FDA:27-JUL-2012 AND CELLULAR AND TISSUE-BASED PRODUCTS (HCT/Ps) c. 0 CHANGE IN INFORMATION

{See reverse side for instructions) d.n INACTNE PART 1- ESTABLISHMENT INFORMATION PART II- PRODUCT INFORMATION oc~ "'"'- tDO:::tt-"

TUn;-" mm!'"' a ;;em~ 3. OlliER FDA REGISTRATIONS 10. ESTABLISHMENT FUNCTIONS AND TYPES OF HCT IPs ·

:OU::z: ""'"' r-CCl::t -"o nco oGJ-Cn ~:o ....

~s~ GJ<nr---i 14. PROPRIETARY a. BLOOD FDA 2830 NO. Establishment Functions ~~~ om• ~~~: NAME(S)

Pack'90 I P<o~s oO mo .- 0

Types of HCT IPs z S> 0 &; b. DEVICES FDA 2891 NO. Recover SctoCJn Test Sto<O Label Distribute !:; "" "' m "'

I "' f,l


4. PHYSICAL LOCATION (Include legal name, number and street. city, state, count:y, and a. Bone X X X X post offJCe code}

Kiev City FM Bureau (KV4) b. Cartilage X X X X

Oranzhereinaya c. Comea

Street-9

Kiev, 04112 d. Dura Mater Ukraine I

OSIP

l I I e. Embryo 0 Directed a. PHONE 49913499880 EXT 0 Anonvmous b.Q SATELLITE RECOVERY ESTABLISHMENT

f. Fascia ! X X I X X I D(MANUFACTURING ESTABLISHMENT FEI NO. I c. TESTING FOR MICRO-oRGANISMS ONLY

I 5. ENTER CORRECTIONS TO ITEM 4 g. Heart Valve i

' I I h. Ligament i X X X X

6. MAJUNG ADDRESS OF REPORTING OFFICIAL (Include insfilutioc name if appjj~ Os1P l

i. Oocyte 0 Directed l number and street, city, state, country. and post office code) 0 Anonymous i RTI Biologics, Inc.

j. Pericardium X X i X X I Attn: Cheryl L. Bagwell, CTBS I 11621 Research Circle k. Peripheral 0 Autologous

I Alachua, Florida 32615 Blood Stem 0 Family Related 0 AJiogeneic

I. Sclera I

0SIP '

I i a. PHONE386-4!8-8888 EXT 4564 1 m. Semen B Directed I 7. ENTER CORRECTIONS TO ITEM 6 Anonymous

b. PHONE I n. Skin X X X

i X I

o. Somatic Cell 0Autologous I I Therapy EJ Family Related Products Alloqeneic I

8. U.S. AGENT Cheryl L. Bagwell, CTBS p. Ten<lon X X X RTI Biologics, Inc. X

l1621 Research Circle, Alachua, Florida 32615 q. Umbilical bJ Autologous

I Cord Blood 0 Family Related 0 Allogeneic

·-a. E-MAIL [email protected] 386-4]8-8888-4564 r. Vascular Graft I I I

9. REPORTING OFFICIAL'S SIGNATURE ' s. I

I i,

l

I I a. TYPED NAME Cheryl L. Bagwell, CTBS I b. E-MAIL [email protected] u.

I I ' I i c. TITLE Compliance Manager d. DATE 28-NOV-2011 Y.

I I I FORM FDA 3356 (11/11)





Authorization Letter from Ministry of Health ofUkraille Bioimptant is on file at Tutogcn Medical, Inc_ a wholly owned

subsidiary of RTI Biologics, Inc. in Alachua, Florida location. This letter allows Karl Koscbatzky, President ofTutogen Medical, GmbH, in Neunkirchen, Germany to register the Ukraine recovery sites with the FDA Please contact Cheryl Bagwell for a copy if necessary.



FORM FDA 3356 {11/11)

1. REGISTRATION NUMBER (FDA Estz..bl~h!Tlf!nt Identifier)

FEI: 3007084785

See Instructions for OMS Statement FORM APPROVED: OMS No. 0910-0543. Expiration Da1e: 1/31/14

I !

Page:2

See lr.strudior.::. for OMS Sta!crnent FORM APPROVED: OMB No. 091().0543. Expiration Date: 1131114

DEPARTMENT OF HEALTH AND HUMAN SERVICES 1. REGISTRATION NUMBER I 2. REASON FOR SUBMISSION VALIDATION-FOR FDA USE ONLY 1

PUBLIC HEALTH SERVICE (FDA Establishr..ent ldentifrer) a. 0 INITIAL REGISTRATION I LISTING VALIDATED BY FDA:OS-QCT-2011 FOOD AND DRUG ADMINISTRATION

b. 0 ANNUAL REGiSTRATION I LISTING ~~~~~~~t~~rzr;:~~-~~p ESTABLISHMENT REGISTRATION AND LISTING FOR HUMAN CELLS, TISSUES, FEI: 3007084847 AND CELLULAR AND TISSUE-BASED PRODUCTS (HCT/Ps) c.lXJ CHANGE IN INFORMATION INACTIVE

(See reverse side for instructions) d. Fxi INACTIVE

PART I· ESTABLISHMENT INFORMATION PART II- PRODUCT INFORMATION i !;n~~ ""' ' c:IO::;:g....o. rnm a ;.urn~

3. OTHER FDA REGISTRATIONS """:r oo rCQ:r;

l 10. ESTABLISHMENT FUNCTIONS AND TYPES OF HCT IPs -"" ~~ oG'lc:o

~, .... oCilr---1

NO. Establishment Functions ~~: ........ ~g~~ 14. PROPRIETARY a BLOOD FDA 2830 om NAME(S)

Sc'"~ I Toot Sto .. I l..>b<l

me .... 0

Types of HCT IPs z $.)> 0 > . b. DEVICES FDA 2891 NO. I l«>covo• Package ProceS3 Distribute ~ a~ ~ "'I

! I g

I c. DRUG FDA 2656 NO. I : 4. PHYSICAL LOCATION (InduCe ~ga[ name, number and street, city, state:, country, and

I I

i a. Bone X X ' X I X post office code} i '

Zak.arpatskoje Regional Forensic Medical Bureau (UZ!) X ! X X I I X b.Gartilage i ! I '

K.apushanskava Street- 22 ' I I I

' c. Cornea

I I Uzhgorod, 88000 I

Ukraine d. Dura Mater i I --

OsiP i ~ I e. Embryo 0 Directed i

I i a. PHONE 49913499880 EXT 0 Anonymous \ b.o SATELLITE RECOVERY ESTABLISHMENT I

X X X I X I i n(I.'ANUFACTURING ESTABLISHMENT FEI NO. f. Fascia I I c. U TESTING FOR MICRO-QRGANISMS ONLY

I I 5. ENTER CORREC110NS TO ITEM 4 g. Heart Valve

h. Ligament X X X X I I I

0 SIP I I 6. MAILING ADDRESS OF REPORTING OFFICIAL (Include institution name if applicable, i. Oocyte 0 Directed

number and street, city, state, country, and post office code) 0 Anonymous I I RTI Biologics, inc.

j. Pericardium X X I X X Attn: Cheryl L Bagwell, CTBS ' 11621 Research Circle k. Peripheral R Autologous

Alachua, Florida 32615 Blood Stem 0 Family Related 0 AJ[ogeneic

I I I. Sclera I I

0SIP I I I I a. PHONE 386-418-8888 EXT 4564 m. Semen 0 Directed ! 7. ENTER CORRECTIONS TO ITEM 6 0 Anonymous I

b. PHONE I ! n. Skin X X X I X I !

o. Somatic Cell 0 Autologous i Therapy R,Family Related I Products Alloqeneic I

8. U.S. AGENT Cheryl L. Bagwell, CTBS p. Tendon X X X X i RTI Biologics, Inc.

11621 Research Circle, Alachua, Florida32615 q. Umbilical i=JAutologous I ! Cord Blood 0 Family Related I

0 Allogeneic ' i

a. E-MAIL [email protected] 386-418-8888-4564 r. Vascular Graft 1

9, REPOR11NG OFFICIAL'S SIGNATURE s. i I

t.

I I a. TYPED NAME Cheryl L. Bagwell, CTBS ' b. E-MAIL [email protected]

u. I \ ! I c. T1TLE Compliance Manager d. DATE 28-NOV-20ll V.

·-·

I I I I

FORM FDA 3356 (11/11)

See Instructions for OMS State;T~ent FORM APPROVED: OMB No. 0910-0543. Expiration Date: 1/31114

DEPARTMENT OF HEALTH AND HUMAN SERVICES 1. REGISTRATION NUMBER 2. REASON FOR SUBMISSION VALIDATION-FOR FDA USE ONLY , I PUBLIC HEAL lH SERVICE (FDA Es:tabl;shment Identifier) a. 0 INITIAL REGISTRATION I LISTING VALIDATED BY FDA:2!>-NOV-2011

FOOD AND DRUG ADMINISTRA TIDN b.IKJ ANNUAL REGISTRAllON I LISTING DISTRICT: lnt'l Operations Group

I ESTABLISHMENT REGISTRATION AND LISTING FOR HUMAN CELLS, TISSUES, FEI: 3007084889 I PRINTED BY FDA:27-JUL-2012

AND CELLULAR AND TISSUE-BASED PRODUCTS (HCT/Ps) ! c. 0 CHANGE IN INFORMAllON

{See reverse side. for instructions) d. n INACllVE

PART 1- ESTABLISHMENT INFORMATION PART II- PRODUCT INFORMATION \ ~~;: "'" CJO:::D_. mm Q::z!m~

3. OTIIER FDA REGISTRATIONS ""'" oGl r-C:Gl::J: 10. ESTABLISHMENT FUNCTIONS AND TYPES OF HCT IPs -on \)~ oG.Jcn

I :i~;s ~~:;;s 14. PROPRIETARY NO. Establishment Functions .-_,

a. BLOOD FDA 2830 i ~~~~~ em g:tln:~ NAME(S) I

me I.- o Types of HCT IPs Pack.rlgo : Proce~

z Er:. c >

b. DEVICES FDA 2891 NO. Recover """"'" Test Store '-"""I OistriPute ~ li!! "' '

~ !

c. DRUG FDA 2656 NO. i 4. PHYSICAL LOCATION (Include legal name, number and street, city, state, coun~ry. and

a. Bone X I X i I X X post office code) I I I

Sumy Regional FYI Bureau (SMI) b. Cartilage X X i X X I

Street of20 Year of Victory- 13 ' c. Comea I

Sumv, 40021 ' I I I Ukraine d. Dura Mater I I I

Os1P I I

e. Embryo 0 Directed a. PHONE 49913499880 EXT 0 Anonymous o.n SATELLITE RECOVERY ESTABLISHMENT

f_ Fascia X X X X [](MANUFACTURING ESTABLISHMENT FEI NO. I c. TESllNG FOR MICRO-ORGANISMS ONLY I

5. ENTER CORRECTIONS TO ITEM 4 1 g. Heart Valve ! I I ' I

h. Ligament X X X i X

0 SIP I 6. MAILING ADDRESS OF REPORTING OFFICIAL (Include ins~tution name if applie2ble, i. Oocyte 0 Direcled number and street, dty, state, country, and post oflioe code) I 0 Anonymous

RTI Biologics, Inc. j. Pericardium X X X X I Attn: Cheryl L. Bagwell, CTBS

11621 Research Circle k.. Peripheral 0 Autologous

! Alachua, Florida 3 2615 Blood Stem 0 Family Related

0Allogeneic

!.Sclera i 0SIP

I I I a. PHONE 386-418-8888 EXT4564 m. Semen R Directed 7. ENTER CORRECTIONS TO ITEM 6 Anonvmous

b. PHONE ! I n. Skin X X X X

' o. Sonatic Cell 0Autologous i I Therapy A Family Related Products Allog_eneic

I

8. U.S. AGENT Cheryl L. Bagwell, CTBS p. Tendon X X ! X X RTI Biologics, Inc.

11621 Research Circle, Alachua, Florida32615 q. Umbilical l=JAutologous

I I Cord Blood 0 Family Related 0AIIogeneic I

a. E-MAJL [email protected] 386-418-8888-4564 r. Vascular Graft I

I l ' 9. REPORTING OFFICIAL'S SIGNA lURE s.

l

I I i a. TYPED NAME Cheryl L. Bagwell, CTBS I


I ' ! c. TITLE Compliance Manager d. DATE 28-NOV-2011 v.

I i I I FORM FDA 3356 (1 1/1 1)


FOOD AND DRUG ADMINISTRATION ESTABUSHMENT REGISTRATION AND LISTING FOR HUMAN CELLS, TISSUES,



Authorization Letter from Ministry of Health ofUkraine Bioimp!ant is on file at Tutogen Medical, Inc. a wholly owned

subsidiary ofRTI Biologics, Inc. in Alachua, Florida location. This letter allows Karl Koschatzky, President of Tutogen Medical, GmbH, in Ncunkirchen, Germany to register the Ukraine recovery sites with the FDA. Please contact Cheryl Bagwell for a copy if necessary.



FORM FDA 3356 (11/11)

1. REGISTRATION NUMBER (FDA E!mlblishment ldentifier)

FEI: 3007084889

See !ns1ruclion.s forOMB Statement FORM APPROVED: OMS No. 0910-0543. Expiration Date: 1/31114

Page:2.

See Instructions for OMS Statement FORM APPROVED: OMB No. 0910-0S43. Expiration Date: 1131114

I DEPARTMENT OF HEALTH AND HUMAN SERVICES 1. REGISTRATION NUMBER i 2. REASON FOR SUBMISSION VALIDATION--FOR FDA USE ONLY 1

PUBLIC HEALTH SERVICE (FDA Establishment Identifier) a. 0 INITIAL REGISTRATION I LISTING VALIDATED BY FDA:29-NOV-2011 FOOD AND DRUG ADMINISTRATION b. 00 ANNUAL REGISTRATION /LISTING DISTRICT: lnfl Operations Group

ESTABLISHMENT REGISTRATION AND LISTING FOR HUMAN CELLS, TISSUES, FEI: 3008296951 PRINTED BY FDA:27-JUL-2012 AND CELLULAR AND TISSUE-BASED PRODUCTS (HCT/Ps) c. D CHANGE IN INFORMATION

{See reverse side for instructions} d. Et INACTIVE

PART 1- ESTABLISHMENT INFORMATION PART II- PRODUCT INFORMATION no~ .,,~

5i:~~ ""rrt=-" rom!" ""':r: £!~::: 1 cGl:J:

3. OlllER FDA. REGISTRATIONS 10. ESTABLISHMENT FUNCTIONS AND TYPES OF HCT IPs ~on oCH:=.n

~i~ ~5~ r:i)U)~....; 14. PROPRIETARY NO. Establishment Functions no~~ a. BLOOD FDA 2830 oO om• ;ta.:::tlmUI NAME(S) mo r 0

Types of HCT I Ps z !S> 0 ~

b. DEVICES FDA 2891 NO. Recover Screen Test Pac:kage Prooess Ston> !.abo I Distribute " OU> "' "' m c: ------ "' " !

I"' c. DRUG FDA 2656 NO. I ! ! i

4. PHYSICAL LOCATION (Include legal name, number and siJ"eet, city. state, country, and X X X X ' a. Bone post office code) I

Chemigov Regional Parhologoanatomic Bureau (CV2) b. Cartilage X X \ X I X

Pigorov Street 18 c. Cornea I Chernigov, 14005 I I Ukraine d. Dura Mater I I

I

0SIP I I e. Embryo D Directed

a. PHONE 49913499880 EXT D Anonymous I I

b.o SATELLITE RECOVERY ESTABLISHMENT f. Fascia X X X X J ! D(MANUFACTURING ESTABLISHMENT FE! NO.

I c. TESTING FOR MICRO-<JRGANISMS ONLY I I

5. ENTER CORRECTIONS TO ITEM 4 g. Heart Valve

h. Ligament X X X X I

.... DSIP 6. MAIUNG ADDRESS OF REPORTING OFFICIAL (Include instilution name if applicable, i. Oocyte D Directed

I number and street, city, state, country, and post offire code) 0 Anonymous

RTI Biologics, Inc. j. Pericardium X X X X

Attn: Cheryl L. Bagwell, CTBS 11621 Research Circle k. Peripheral D Autologous

Alachua, Florida 32615 Blood Stem D Family Related 0AIIogeneic

I. Sdera ...

0SIP

I a. PHONE 386-418-8888 EXT 4564 m.Semen D Directed

7. ENTER CORRECTIONS TO ITEM 6 0Anonymous b. PHONE

I n. Skin X X X X

o. Somatic Ce\1 D Aulologous

I Therapy 8 Family Related Products AIIO!leneic

6. U.S. AGENT Cheryl L. Bagwell, CTBS ' I I p. Tendon X X X X RTf Biologics, Inc.

11621 Research Circle, Alachua, Florida32615 q.Umbilical b,d Autologous

Cord Blood D Family Related 0AIIogeneic I

a. E-MAIL [email protected] 386-418-8888-4564 r. Vascular Graft I 9. REPORTING OFFICIAL'S SIGNATURE s. I

! I 1. i ! a. TYPED NAME Cheryl L. Bagwell, CTBS

I


I I ' I c. TITLE Compliance Manager d. DATE 28-NOV-2011 V. I i I I I

FORM FDA 3356 (11/11)


FOOD AND DFWG ADMINISTRATION ESTABLISHMENT REGISTRATION AND LISTING FOR HUMAN CELLS, TISSUES,

AND CELLULAR AND TISSUE-BASED PRODUCTS (HCT/Ps) {See reverse side for instructions)



subsidiary ofRTI Biologics, L'lc. in Alachua, Florida location. This letter allows Karl Koscbatzky, President ofTutogen Medical, GmbH, in Neunkirchen, Germany to register the Ukraine recovery sites with the FDA. Please contact Cheryl Ba,owell for a copy if necessary.



FORM FDA 3356 (11/11)

1. REGISTRATION NUMBER (FDA Establishment !donbfier)

FEI: 300829695!

See lnstructionsforOMB Statement FORM APPROVED: OMB No. 0910-0543. Exoiration Date: 1131/14

2Jl

I!

Page:2

See lnst:ructions ior OMB Stalement FORM APPROVED: OMS No. 0910..0543. Expiration Date: 1/3'1114

DEPARTMENT OF HEALTH AND HUMAN SERVICES 1. REGISTRATION NUMBER ' 2. REASON FOR SUBMISSION VALIDATIOI>}-FOR FDA USE ONLY 1

PUBLIC HEALTH SERVICE (FDA Establishment Identifier) a. 0 INITIAL REGISTRATION 1 LISTING VALIDATED BY FDA:29-NOV·2011 FOOD AND DRUG ADMINISTRATION o. fXJ ANNUAL REGISTRATION I LISTING ~~~~;~~~~~~~~~~~-;O~~p

ESTABLISHMENT REGISTRATION AND LISTING FOR HUMAN CELLS, TISSUES, FEI: 3008832813 AND CELLULAR AND TISSUE-BASED PRODUCTS (HCT/Ps) c. n CHANGE IN INFORMATION

d. Fi INACTIVE !

(See reverse side for instructions) ' PART I· ESTABLISHMENT INFORMATION PART II- PRODUCT INFORMATION

oo~ 3::•~

~~~~~ "Tim~ mm!'"'

""""' OG"l;r 3. OTHER FDA REGISTRATIONS 10. ESTABLISHMENT FUNCTIONS AND TYPES OF HCT IPs §~~ oco oG')Cot

f!S:J 0 cnr---t

Establishment Functions ~g~~ 14. PROPRIETARY a. BLOOD FDA 2830 NO :..,.mu, om• NAME(S) ----- I I

oO mo ... "

Types of ~CT J Ps z :s,. 0 >

b. DEViCES FDA 2891 NO. Recovor 1 Sci'I&Ein Test Packag. Process StaN Label r ..... b ... ~ ~" ~ .,

" " "' c. DRUG FDA 2656 NO.

4. PHYSICAL LOCATION (Include legal name. number and street, city, state. country, and a_ Bone X X X X

post office code)

Dnepropetrovsk Regional Bureau of Forensic Medical Examination (DN3) X X X I

b. Cartilage X I ! I

Leninsky District Department ' Institute for Tissue Procurement

c. Cornea \

Blizbnaja Street, Building 31 d. Dura Mater I I Dnepropetrovsk, 49102 I

Ukraine Ds1P

I I I

e. Embryo D Directed I I I I a. PHONE 49913499880 EXT 0 Anonvmous

b. 0 SATELUTE RECOVERY ESTABLISHMENT f. Fascia X X

I X X

o(MANUFACTURING ESTABLISHMENT FEI NO. c. TESTING FOR MICRO-ORGANISMS ONLY

5. ENTER CORRECTIONS TO ITEM 4 g. Heart Valve

h. Ligament X X X I X

0 SIP

I 6. MAILING ADDRESS OF REPORTING OFFICIAL (Include institution name if applicable, i. Oocyte D Directed I number and street, city, state, country, and post office code} 0 Anonymous

1

RTI Biologics, Inc. j_ Pericardium X X I X X Attn: CherylL. Bagwel~ CTBS 11621 Research Circle k. Peripheral 0 Autologous

Alachua, Florida 32615 Blood Stem 0 Family Related 0Altog.;neic 1

I. Sclera --~-

OSIP

I I a. PHONE 386-418-8888 EXT4564 m.Semen D Directed

7. ENTER CORREC"TlONS TO ITEM 6 0Anonvmous b. PHONE

n. Skin X X X I X I I

o _ Soma~ic Cell D Autologous i I i Therapy l4 ;amity Related Products Alloaeneic


11621 Research Circle, Alachua, Florida32615 q. Umbilical QAutologous

CordBIOO<J 0 Family Related 0 Allogeneic

a. E-MAIL [email protected] 386-418-8888-4564 r. Vascular Graft i I 9. REPORTING OFFICIA.L"S SIGNA. TURE S.

I I i I I !.

! ! I

a. TYPED NAME Cheryl L. Bagwel~ CTBS I I


I I I

c. TITI.E Compliance Manager d. DATE 28-NOV-2011 v. i ' I FORM FOA3356 (11/11)

DEPARTM~NT OF HEALTH AND HUMAN SERVICES PUBLIC HEALTH SERVICE


AND CELlULAR AND TISSUE-BASED PRODUCTS {HCT/Ps) (See reverse side for instructions)


Authorization Letter from Ministry of Health of Ukraine Bioimplam is on file at Tutogen Medical, Inc. a wholly owned subsidiary ofRTI Biologics, Inc. in Alachua, Florida location. This letter allows Karl Koschatzky, President ofTutogen Medical, GmbH, in Neunkirchen, Germany to register the Ukraine recovery sites with the FDA. Please contact Cheryl Ba,crwell for a copy if necessary.

T utogen Medical, Inc. a wholly owned subsidiary of RTI Biologics, Inc.


FORM FDA 3356 (11111)

1. REGISTRATION NUMBER (FDA Establishment ldentifi~r)

FEI: 30088328 J3

See. Instructions fOlOMB Slatemenl FORM APPROVED: OMS No. 0910-0543. Expiration Date: 1/31114

2 II li II li

Page:2

Seo lnstrud.ions for OMS Statement FORM APPROVED: OMS No. 0910-0543. Expiration Date: 1/31114

I DEPARTMENT OF HEALTH AND HUMAl\1 SERVICES 1. REGISTRATION NUMBER I 2. REASON FOR SUBMISSION I VALIDATION-FOR FDA USE ONLY 1 I PUBLIC HEALTH SERVICE (FDA Establishment Identifier) a. 0 INITIAL REGISTRATION I LISTING . VALIDATED BY FDA:29·NOV-2011 FOOD AND DRUG ADMINISTRATION I b. [iJ ANNUAL REGISTRATION I LISTING DISTRICT: ln\1 Operations Group

ESTABLISHMENT REGISTRATION AND LISTING FOR HUMAN CELLS, TISSUES, FEI: 3008832848 0 PRINTED BY FDA:27-JUL-2012 AND CELLULAR AND TISSUE-BASED PRODUCTS (HCT/Ps) c. CHANGE IN INFORMATION

(See reverse side for instruct:oos) d. n INACTIVE PART I- ESTABLISHMENT INFORMATION ' PART II -PRODUCT INFORMATION POll ;:>J>! ~o~~ 3. OTHER FDA REGISTRATIONS 10. ESTABLISHMENT FUNCTIONS AND TYPES OF HCT IPs ~~~ s;g~i ~§§;

a. BLOOD FDA 2830 NO. Establishment Functions :i;~ ~~~~ ~~):~ 14. PROPRIETARY :.g:•l em•' ~~;;!· NAME(S) Tyf>"s of HCT I Ps 1 ° z ~~ f ~ ~

b. DEVICES FDA 2891 NO. Rocovet Semen Test Package: ProCllss Stem L.abol I Distribute ~ ~a. l ~ Cll

I I . '" i"' I I" c. DRUG FDA 2656 NO. . I I

4. PHYSICAL lOCATION (Include legal name, m.Jtr..barand street, city, state, country, and a. Bone X X

i,

I X i X · post office rode) I I

Donetzk Regional Bureau offorensic Medical Examination- Mariupol '

! I Department (MLI) b. Cartilage X X J X X

Uchebnv Lane 3 ' I I

I c. Cornea I ! 4th Post Office of lllichevslcy District I Donetzk Region I ' I I

d. Dura Mater I i I I Mariupol, 87504 I I ! Ukraine OSIP I

I I I e. Embryo 0 Directed

! I a. PHONE 49913499880 EXT 0 Anonvmous I

b.Q SATIELUTIE RECOVERY EST.'IBLISHMENT I f. Fascia X I X i I X X i o(MANUFACTURING ESTABLISHMENT FEI NO.

! c. :ESTING FOR MICRO-ORGANISMS ONLY !

I g. Heart Valve I I 5. ENTER CORRECTIONS TO ITEM 4

I h. Ligament

I ~ I

X X I

X X i 0 SIP I

6. MAILING ADDRESS OF REPORTING OFFICIAL (Include institution name if applicable, i. Oocyte 0 Directed ! number and street, dt:y, state. country, and post office code) 0 Anonymous

RTI Biologics, Inc. j. Pericardium X X X X Attn: Cheryl L. Bagwell, CTBS

11621 Research Circle k. Peripheral Q Autologous -T Alachua, Florida 32615 Blood Stem 0 Family Related 0 Allogeneic

I. Sclera ! I I

' OstP I I I

a. PHONE386-418-8888 EXT4564 m. Semen ODirected I 7. ENTER CORRECTIONS TO ITEM 6 FJAnonvmous 1

b. PHONE

I n. Skin X X X X

i I

I o. Somatic Cell 0 Autologous

I i Tnerapy R Family Related I Products A!loOOneic

8. U.S_ AGENT Cheryl L. Bagwell, CTBS p. Tendon X X X X RTI Biologics, Inc. 11621 Research Circle, Alachua, Florida 32615

q. Umbilical !=j Autoiogous Cord Blood 0 Family Related

0 Allogeneic

a. E-MAIL [email protected] 386-418-8888-4564 r. Vascular Graft i i I

I 9. REPORnNG OFFICIAL"S SIGNA TIJRE s. I i i I I

i I l I

I.

I I I

a. TYPED NAME Cheryl L. Bagwell, CTBS '

b. E-MAIL [email protected] u. I I I

I c. TITLE Compliance Manager d. DATE 28-NOV-201! V.

I I FORM FDA 3356 (11/11)

DEPARTMENT OF HEALTH AND HUMAN SERVICES PUBLIC HEAL 11-1 SERVICE





subsidiary ofRTI Biologics, Inc. in Alachua, Florida location. This letter allows Karl Koschatzky, President ofTutogen Medical, GmbH, in Neunkirchen, Germany to register the Ukraine recovery sites with the FDA. Please contact Cheryl Bagwell for a copy if necessary.

Tutogen. Medical, Inc. a wholly owned subsidiary of RTI Biologics, Inc.

Proprietal)' Name(s):

FORM FDA 3356 {11/11)

1. REGISTRATION NUMBER (FDA Establishment :Oenlifier)

FEI: 3008832848

Sec Instructions torOMB St<:atement FORM APPROVED: OMB No. 09~0....0543. Expiration Date: i/31114

Page:2

Soe Instructions for OMS Statemenl FORM APPROVED: OMB No. 0910-0543. Expiration Date: 1/31/14

DEPARTMENT OF HEALTH AND HUMAN SERVICES 1. REGISTRATION NUMBER 2. REASON FOR SUBMISSION VALIDATION-FOR FDA USE ONLY 1 I PUBLIC HEALTH SERVICE (FDA Establishment ldenti~er} a. 0 INITIAL REGISTRATION I LISTING VALIDATED BY FDA:29-NOV-2011

FOOD AND DRUG ADMINISTRATION b. [Kj ANNUAL REGISTRATION /LISTING DISTRICT: ln1'1 Operations Group ESTABLISHMENT REGISTRATION AND LISTING FOR HUMAN CELLS, TISSUES, FE!: 3009193797

c. 0 CHANGE IN INFORMATION PRINTED BY FDA:27-JUL-2012

AND CELLULAR AND TISSUE-BASED PRODUCTS (HCT/Ps) (See reverse side for instructions) d. D INACTIVE

PART I- ESTABLISHMENT INFORMATION PART II- PRODUCT INFORMATION ! '"~:::1 jl;~O:: ~g~~t 3. OlliER FDA REGISTRATIONS 10. ESTABLISHMENT FUNCTIONS AND TYPES OF HCT I Ps '==~:r !:!g:x: ~CG):r

' ... ;:u~ 0>~ oG)c(')

::ttD1:i ~-i~ Q(oll~:--4 14. PROPRIETARY NO. Establishment Functions ()0-t.:U a. BLOOD FDA 2830 ~~Ill g~"' >;:am:n NAME(S)

' ~ 0

oypes of HCT I Ps I : % ~> 0 ;;; b. DEVICES FDA 2891 NO. Rocover Scro&n To:st Paebge Process Store:~ Label Oistrlbutci ~ E "' "' " " I "' c. DRUG FDA 2656 NO.

i i

4. PHYSICAL LOCATION (lndude legal name, number and street. city, state, country, and a. Bone X X I X :x

1 post office code) I

Pathoanatornical Department of the Lugansk City Multifield Hospital #9 ' I b. Canilage X X X X ' (LUG2)

\ I

Block 50-year Amriversary of Defense of I I c. Cornea i Defense of Lugansk I

I I Building 12V d. Dura Ma1er i i Lugansk, 91045 I

Ukraine Osrp I i i e. Embryo 0 Directed

I I

a. PHONE 49913499880 EXT \ 0 Anonvroous i b.o SATELLITE RECOVERY ESTABUSHMENT I

X X I X X ~(MANUFACTURING ESTABLISHMENT FEI NO. f. Fascia

c. U TESTING FOR MICRO-ORGANISMS ONLY I

5. ENTER CORRECTIONS TO ITEM 4 g. Heart Valve I ·-·-·

h. Ligament X X !

X X

0 SIP 6. MAILING ADDRESS OF REPORTING OFFICIAL (Include institution name~ applicable, i. Oocyte 0 Directed I number and street. city, state, country, and post office code) 0 Anonymous

RTI Biologics, Inc. j. Pericardium X X i X X

Attn: Cheryl L. Bagwell, CTBS ! 11621 Research Circle k. Peripheral 0 Autologous I

J

Alachua, Florida 32615 Blood Stem 0 Family Related I

I 0AIIogeneic I

I. Sclera I i I OSIP

I i

I a. PHONE 386-418-8888 EXT4564 m.Semen 0 Directed

'7. ENTER CORRECTIONS TO ITEM 6 -- 0Anonymous b. PHONE

n. Skin X X X X

a. Somatic Cell 0 Autologous I Therapy 0 Family Related

I

Producls [J Allogeneic i

8. U.S. AGENT Cheryl L. Bagwell, CTBS p. Tendon X X X I X RTI Biologics, Inc.

11621 Research Circle, Alachua, Florida 32615 q. Umbilical l , Autologous

! I

Cord Blood 0 Family Related 0 Allogeneic i

T-· a. E-MAIL [email protected] 386-418-8888-4564 r. Vascular Grait I i I

9. REPORTING OFFICIAL'S SIGNATURE s. I ! i \ I. i

a. TYPED NAME Cheryl L Bagwell, CTBS i

b. E-MAIL [email protected] u. I

I -· c. TITlE Compliance Manager d. DATE 28-NOV-2011 v. I I I I

i

' FORM FDA 3356 (11/11)



AND CELLULAR AND TISSUE-BASED PRODUCTS (HCT/Ps) (See reverse side.1or instructions)



subsidiary ofRTI Biologics, Inc. in Alachua, Florida location. This letter allows Karl Koschatzky, President of Tutogen Medical, GmbH, in Neunk:ircben, Germany to register the Ukraine recovery sites with the FDA. Please contact Cheryl Bagwell for a copy if necessary.

Tutogen Medical, Inc. a wholly owned subsidiary of RTI Biologics, Inc.


FORM FDA 3356 (11/11}

1. REGISTRATION NUMBER (FDA Est3blish:T"'eh1 Identifier)

FEI: 3009193797

Seelns1ructlonstorOM8 Statemen'l FORM APPROVED: OMB No. 0910-0543 Expiration Date: 1/31/14 2

Page:2

Documents

DEPARTMENT OF HEALTH & HUMAN SERVICES · See Instructions fotOMB Statement FORM APPROVED: OMB No. 0910-0543. Expiration Date: 1/31114 DEPARTMENT OF HEALTH AND HUMAN SERVICES 1. REGISTRATION