SSinince ce 11969565 Part: First (A) Jimco Revision level: 01 · 2019-07-05 · approved, batch number is also indicated on the label and shifted to approved material/ in-process

Manufacturer , Exporter & Importers of

Surgical, Dental, Rehabilitation &

Sterile Disposable Instruments

J imco I n d u s t r i e sR

Since 1965Since 1965Since 1965

JimcoIndustries

Technical Information/ Part: First (A)

Revision level: 01

Copy # SP/01

Page. # 3Specification # JI/CE/PACKS/A

6.0 Construction/Design

CONSTRUCTION/DESIGN DETAILS OF NON-METAL MEDICAL DEVICES FOR PACKS.

All the metal medical devices included in the packs/ kits covered by this document are the instruments manufactured and packaged under Technical Information/ Specification # JI/CE/SDI/ASome non-metal medical devices are also included in some of the procedure packs. Their detail with intended use, classification, applicable rules, justification and description is as under

Item # Common / usual name Size General Description of the device, material used

Classification & relevant rule Intended use (brief description of the devices)JustificationRule# Class

Sterile crepe sheet StandardSingle use Sterile Super crepe sheet made of medical grade polyester fabric 1 1

single usenon-invasive

Keeps instruments safe from malicious micro-organisiums

The above stated products are purchased in finished form. Upon receipt the above are placed in incoming area where visual inspection of the materials is made and accompanied documents like material report/safety data sheet if applicable, if any are reviewed for verification. In case of approval the material is indicated as approved, batch number is also indicated on the label and shifted to approved material/ in-process store. Results of inspection are recorded on the office copy of relevant purchase order. The rejected materials will be handled according to Control of Non-conforming product Procedure (SOP#10). The Material Data Sheets are part of second Part (B) of Technical File.

In the Clean Room, 100% inspection of the above stated products is made once again and these are included in the relevant procedure packs/ kit alongwith other desired metal medical instruments produced under technical file number JI/CE/SDI/A.

The above products are only included in the following procedure packets/ kits DA-001-001 /DA-007-001

In the next sub-sections of this document the relevant packs/ kits compiled out of these medical devices have been identified with their description, sizes, intended use, classification, applicable rule, justification.

UC-1 Clamp StandardSingle use Umbilical Cold Clamp is Made

rom medical grade ABS, Nylon or PE, and POLY 6 11A

Single useSurgicallyinvasivetransientuse

hold the umbilical cord

4.0 Name and Address of the Manufacturer

4.1. Manufacturer: Jimco Industries,

4-Km, Aimen Abad Road,

Near Akbar Abad Chowk, Sialkot, Pakistan

4.2. Authorized Representative : Jimco Healthcare UK, 16 Devonshire Road, Middlesbrough TS5 6DP, London, UK.

5.0 Name and Address of the facilities

5.1 Manufacturer: Jimco Industries, (Same as above)

4-Km, Aimen Abad Road,

Near Akbar Abad Chowk, Sialkot, Pakistan






JimcoIndustries


Revision level: 01

Copy # SP/01

Page. #4Specification # JI/CE/PACKS/A

NUMBER OF PACKS WITH DIFFERENT SPECIFICATION:- 04-

DEVICE FAMILY:- SCISSORS / ARTERY FORCEPS / DRESSING & TISSUE FORCEPS / NEEDLE HOLDERS

JUSTIFICATION:- PACKS OF DIFFERENT INSTRUMENTS HIGHER CLASS APPLICABLE

BRIEF INTENDED USE:- SEE BELOW COLUMN FOR EACH PACK DECEIVES.






JimcoIndustries


Revision level: 01

Copy # SP/01


Common / Usual NameArt NumbersClassification & relevant rule Intended use

(brief description of the devices)

Reference to Manufacturing

procedure/ MethodRule# Class Justification

6

STERILE STANDARD SUTURE PACK Single Use Instruments Pack contain 4-PC 1Pc. Kilner Needle Holder 5".Made of stainless steel of Grade- 410 1 Pc. Stitch Scissors 4.5" STR. Made of stainless steel of Grade- 420 1Pc. Treeves 1x2 Dissecting Forceps 5". Made of stainless steel of Grade- 410 1Pc. T.O.E. (Turnover End) Forceps 5". Made of stainless steel of Grade- 410

1Pc. Sterile Super Crepe Sheet.Keeps instruments safe from malicious micro-organisiums

DA-001-001 Closure of wound in ordinary surgery procedure

JI/CE/PACKS/A PACKS OF DIFFERENT

INSTRUMENTS HIGHER

CLASS APPLICABLE

6 IIA PACKS OF DIFFERENT

INSTRUMENTS HIGHER

CLASS APPLICABLEJI/CE/PACKS/A DA-001-003

STERILE SUTURE PROCEDURE PACK Single Use Instruments Pack contain 2-PC 1 Pc Spencer Ligature Scissors, 9cmMade of stainless steel of Grade- 420 1 Pc Adson Tissue Forceps 1x2 (Fine), 12cm. Made of stainless steel of Grade- 410

DA-001-004 STERILE SUTURE REMOVAL PACK Single Use Instruments Pack contain 2-PC 1 Pc Iris Scissors Straight 11.5 cm Made of stainless steel of Grade- 420 1 Pc Adson Tissue Forceps 1x2 (Fine), 12cm. Made of stainless steel of Grade- 410

To finalize & closure of woundin surgery with carefully

6

IIA

IIA PACKS OF DIFFERENT

INSTRUMENTS HIGHER

CLASS APPLICABLE

To finalize & closure of woundin surgery with carefully

JI/CE/PACKS/A

DA-007-001 STERILE STANDARD DELIVERY PACK Single Use Instruments Pack contain 4-PC - 2-PC CLAMPS

1Pc. Umbilical Cord Scissor 4¼"Made of stainless steel of Grade- 420 1Pc. Mayo Scissor 7" STR.Made of stainless steel of Grade- 420

2Pc. Spencer Wells 5" STR.S/S Made of stainless steel of Grade- 410

2Pc. Umbilical Cord Clamps.Made From Medical Grade Abs, Nylon Or Pe, And Poly

1Pc. Sterile Super Crepe Sheet.Keeps instruments safe from malicious micro-organisiums

6 IIA PACKS OF DIFFERENT

INSTRUMENTS HIGHER

CLASS APPLICABLE

JI/CE/PACKS/A

Umbililcal cord care and/or dressingduring gynecologicalexamination

DEVICE SPECIFICATION /DATA SHEET

STERILE Kilner Needle Holder 13CM STAINLESS STEEL - (DISPOSABLE METAL STERILE INSTRUMENTS)

Common / Usual Name

6.1 Identification of the Devices

Family :- Material:- Hardness:‐ NEEDLE HOLDER / AISI 410 / 40 TO 44 HRC.

02 / 30 TO 40 Grm Appox Components:- Products Weight :-

AF-156-19-DCode:-

13.0cm / STRAIGHTSize:-

Disposable Sterile Metal InstrumentsCategory:-

Medical Device Type:-

IIAClass:-

6 Rule #:-

SINGLE USE SURGICALLY INVASIVE TRANSIENT USEJustification:-

HOLD AND PASS THE NEEDLE THROUGH THE TISSUE WHILE SUTURINGIntended Use:-

JI/CE/FCP2Reference To Manufacturing Procedure:-

Ce /stainless Steel / Sign Of Single Use / On Customer RequestMarking:- ( SKU / LOT # )

Gamma Radiation / Dose Level 2.5MRDSterilization Method:-

DuPont Tyvek Sterilization Reels width Size: 10.16 cmPACKING Material:-

Symbol To Be Used On Packing :-

ISO 7153-1, EN ISO 11737-1:2006, ISO 14644 ISO 7153-1,EN ISO 11737-1:2006, ISO 14644Harmonized Standards:-

Since 1965Since 1965

JimcoIndustries





Since 1965

Image Of Products With &with out Coloring Identification Rings.

PEELS T E R I L E R REF LOT EUREPDO NOT USE IF THE

PACKAGING IS DAMAGEDSTORE INSTRUMENTPACK IN A DRY PLACE 2 0000

DA-001-001


Revision level: 01

Copy # SP/01


DEVICE SPECIFICATION FOR STERILE STANDARD SUTURE PACK

PLANNEEDLE HOLDER

Composi�on of Raw Material stainless steel .

0.09 to 0.15 %

1.0% maximum0.040% maximum0.030% maximum1.0% maximum11.5% to 13.5%1.0% maximum

GRADE-410

Detail of Material for Non Cutting Instruments

Jimco Code

AF-156-19-D

Customer Code

Material Type

AISI 410

AISI 304

AISI 420

40-44

Rev

isio

n No

1

2

3

4

5

Date Description

Type-Single Use

Product: Kilner Needle Holder 13cm

FDAApproved

ISO13485

9001-2003Certified

E-mail:[email protected]

Tolerance

xxx

All Dimensions in Millimeters.

5.00

xx 0.50-0.30

x 0.25-0.15

Drawn By:

Approved By

Q.A:Departmet

Managing Director

Jimco Industries 4.KM Aminabad Road, Sialkot, Pakistan.

Phone: +92 52 3611253. Fax: +92 52 3611453

J imco I n d u s t r i e s

6.1 Identification of the DevicesTechnical Drawing & Technical Sheet With Composi�on And Raw Material .


JimcoIndustries



Sterile Disposable InstrumentsTechnical Information/ Part: First (A)

Revision level: 01

Copy # SP/01


Common / Usual Name

Family :- SCISSORS / AISI 420 / 42 TO 46 HRC.Material:- Hardness:‐


AB-208-10-DCode:-




ISClass:-

IRule #:-

SINGLE USE NON SURGICALLY INVASIVEJustification:-

STITCH CUTTING/REMOVALIntended Use:-

JI/CE/SCR3Reference To Manufacturing Procedure:-









STERILE SPENCER STICH Scissors 9.0 CM STAINLESS STEEL - (DISPOSABLE METAL STERILE INSTRUMENTS)


6.1 Identification of the DevicesSince 1965Since 1965

JimcoIndustries





Since 1965

DA-001-001


Revision level: 01

Copy # SP/01



Jimco Code

AB-208-10-D

Customer Code

Material Type

AISI 410

AISI 304

AISI 420 42-46 Rev

isio

n No

1

2

3

4

5

Date Description

Type-Single Use

Product: Spencer Ligature Scissors 9cm

FDAApproved

ISO13485

9001-2003Certified


Tolerance

xxx


5.00

xx 0.50-0.30

x 0.25-0.15

Drawn By:

Approved By

Q.A:Departmet

Managing Director


Phone: +92 52 3611253. Fax: +92 52 3611453


PLANFAMILY SCISSORS




JimcoIndustries




Revision level: 01

Copy # SP/01


STERILE Treeves 1x2 Dissecting Forceps 13CM STAINLESS STEEL - (DISPOSABLE METAL STERILE INSTRUMENTS)

Common / Usual Name

Family :- Material:- Hardness:‐ FORCEPS / AISI 410 / 40TO 44 HRC.


AD-600-01-DCode:-

13.0cm / StraightSize:-



IIAClass:-

6 Rule #:-


HOLDING OF TISSUEIntended Use:-

JI/CE/TW1Reference To Manufacturing Procedure:-











JimcoIndustries





Since 1965

DA-001-001


Revision level: 01

Copy # SP/01



Jimco Code Customer Code

Material Type

AISI 410

AISI 304

AISI 420

40-44

Rev

isio

n No

1

2

3

4

5

Date Description

Type-Single Use

Product: Treeves Toothed Dissecting Forceps 13cm

FDAApproved

ISO13485

9001-2003Certified


Tolerance

xxx


5.00

xx 0.50-0.30

x 0.25-0.15

Drawn By:

Approved By

Q.A:Departmet

Managing Director


Phone: +92 52 3611253. Fax: +92 52 3611453

PLANTissue Forceps


0.09 to 0.15 %


GRADE-410


AD-600-01-D




JimcoIndustries




Revision level: 01

Copy # SP/01


STERILE T.O.E. (Turnover End) Forcep13CM STAINLESS STEEL - (DISPOSABLE METAL STERILE INSTRUMENTS)

Common / Usual Name

Family :- Material:- Hardness:‐ FORCEPS / AISI 410 / 40TO 44 HRC.


AD-610-01-DCode:-




IIAClass:-

6 Rule #:-


RETRACTION, GRASPING, OR DISSECTION OF TISSUE DURING SURGICAL PROCEDURES. HOLDING AND MOVING OF DRESSINGS, SWABSIntended Use:-












JimcoIndustries





Since 1965

DA-001-001


Revision level: 01

Copy # SP/01



PLANTissue Forceps


0.09 to 0.15 %


GRADE-410


AD-610-01-D

Jimco Code Customer Code

Material Type

AISI 410

AISI 304

AISI 420

40-44

Rev

isio

n No

1

2

3

4

5

Date Description

Type-Single Use

Product: T.O.E (Turnover end) Forceps 13cm

FDAApproved

ISO13485

9001-2003Certified


Tolerance

xxx


5.00

xx 0.50-0.30

x 0.25-0.15

Drawn By:

Approved By

Q.A:Departmet

Managing Director


Phone: +92 52 3611253. Fax: +92 52 3611453




JimcoIndustries




Revision level: 01

Copy # SP/01


Common / Usual Name

Family :- SCISSORS / AISI 420 / 42 TO 46 HRC.Material:- Hardness:‐


AB-208-10-DCode:-




ISClass:-

IRule #:-

SINGLE USE NON SURGICALLY INVASIVEJustification:-

STITCH CUTTING/REMOVALIntended Use:-










STERILE SPENCER STICH Scissors 9.0 CM STAINLESS STEEL - (DISPOSABLE METAL STERILE INSTRUMENTS)



JimcoIndustries





Since 1965

DA-001-003


Revision level: 01

Copy # SP/01


DEVICE SPECIFICATION FOR STERILE SUTURE PROCEDURE PACK

Jimco Code

AB-208-10-D

Customer Code

Material Type

AISI 410

AISI 304

AISI 420 42-46 Rev

isio

n No

1

2

3

4

5

Date Description

Type-Single Use

Product: Spencer Ligature Scissors 9cm

FDAApproved

ISO13485

9001-2003Certified


Tolerance

xxx


5.00

xx 0.50-0.30

x 0.25-0.15

Drawn By:

Approved By

Q.A:Departmet

Managing Director


Phone: +92 52 3611253. Fax: +92 52 3611453


PLANFAMILY SCISSORS




JimcoIndustries




Revision level: 01

Copy # SP/01


STERILE ADSON TISSUE FORCEPS 1X2 TEETH STRAIGHT 12CM STAINLESS STEEL - (DISPOSABLE METAL STERILE INSTRUMENTS)

Common / Usual Name

Family :- Material:- Hardness:‐ FORCEPS / AISI 410 / 40 TO 44 HRC.


AD-140-10-D Code:-




IIAClass:-

6 Rule #:-


HOLDING OF DRESSING, SWABS,TISSUE INSERT/ABLATE FOREIGN OBJECTSIntended Use:-












JimcoIndustries





Since 1965

DA-001-003


Revision level: 01

Copy # SP/01




PLANFAMILY DRESSING& TISSUE FORCEPS

0.09 to 0.15 %


GRADE-410


Jimco Code

AD-140-10-D

Customer Code

Material Type

AISI 410

AISI 304

AISI 420

40-44

Rev

isio

n No

1

2

3

4

5

Date Description

Type-Single Use

Product: Adson tissue forceps 1x2 teeth straight 12cm

FDAApproved

ISO13485

9001-2003Certified


Tolerance

xxx


5.00

xx 0.50-0.30

x 0.25-0.15

Drawn By:

Approved By

Q.A:Departmet

Managing Director


Phone: +92 52 3611253. Fax: +92 52 3611453




JimcoIndustries




Revision level: 01

Copy # SP/01




JimcoIndustries





Since 1965

DA-001-004


Revision level: 01

Copy # SP/01


DEVICE SPECIFICATION FOR STERILE SUTURE REMOVAL PACK

STERILE IRIS SCISSORS SHARP/SHARP - STRAIGHT - 11,5CM STAINLESS STEEL DISPOSABLE METAL STERILE INSTRUMENTS

Common / Usual Name

Family :- Material:- Hardness:‐ Scissors / AISI 420 / 42 TO 46 HRC.


AB-180-14-DCode:-




IIAClass:-

6 Rule #:-

Single Use Surgically InvasiveJustification:-

Cutting Hard TissueIntended Use:-










Jimco Code

AB-180-14-D

Customer Code

Material Type

AISI 410

AISI 304

AISI 420 42-46 Rev

isio

n No

1

2

3

4

5

Date Description

Type-Single Use

Product: Iris scissors sharp/sharp - straight - 11,5cm

FDAApproved

ISO13485

9001-2003Certified


Tolerance

xxx


5.00

xx 0.50-0.30

x 0.25-0.15

Drawn By:

Approved By

Q.A:Departmet

Managing Director


Phone: +92 52 3611253. Fax: +92 52 3611453





JimcoIndustries




Revision level: 01

Copy # SP/01


PLANFAMILY SCISSORS

STERILE ADSON TISSUE FORCEPS 1X2 TEETH STRAIGHT 12CM STAINLESS STEEL - (DISPOSABLE METAL STERILE INSTRUMENTS)

Common / Usual Name



AD-140-10-D Code:-




IIAClass:-

6 Rule #:-


HOLDING OF DRESSING, SWABS,TISSUE INSERT/ABLATE FOREIGN OBJECTSIntended Use:-












JimcoIndustries





Since 1965

DA-001-004


Revision level: 01

Copy # SP/01






JimcoIndustries




Revision level: 01

Copy # SP/01



PLANFAMILY DRESSING& TISSUE FORCEPS

0.09 to 0.15 %


GRADE-410


Jimco Code

AD-140-10-D

Customer Code

Material Type

AISI 410

AISI 304

AISI 420

40-44

Rev

isio

n No

1

2

3

4

5

Date Description

Type-Single Use

Product: Adson tissue forceps 1x2 teeth straight 12cm

FDAApproved

ISO13485

9001-2003Certified


Tolerance

xxx


5.00

xx 0.50-0.30

x 0.25-0.15

Drawn By:

Approved By

Q.A:Departmet

Managing Director


Phone: +92 52 3611253. Fax: +92 52 3611453

STERILE US MOD. UMBILICAL SCISSORS 10.5CM STAINLESS STEEL (DISPOSABLE METAL STERILE INSTRUMENTS)

Common / Usual Name

Family :- Scissors / AISI 420 / 42 TO 46 HRC.Material:- Hardness:‐


AB-150-50-DCode:-




ISClass:-

1Rule #:-

Single Use Non Surgically InvasiveJustification:-

CUT UMBILICAL CORDIntended Use:-


CE/STAINLESS STEEL / Sign Of Single Use / On Customer RequestMarking:- ( SKU / LOT # )










JimcoIndustries





Since 1965

DA-007-001


Revision level: 01

Copy # SP/01


DEVICE SPECIFICATION FOR STERILE STANDARD DELIVERY PACK


PLANFAMILY SCISSORS

Jimco Code

AB-150-50-D

Customer Code

Material Type

AISI 410

AISI 304

AISI 420 42-46 Rev

isio

n No

1

2

3

4

5

Date Description

Type-Single Use

Product: US MOD. UMBILICAL SCISSORS 10.5CM STAINLESS STEEL

FDAApproved

ISO13485

9001-2003Certified


Tolerance

xxx


5.00

xx 0.50-0.30

x 0.25-0.15

Drawn By:

Approved By

Q.A:Departmet

Managing Director


Phone: +92 52 3611253. Fax: +92 52 3611453




JimcoIndustries




Revision level: 01

Copy # SP/01


STERILE MAYO SCISSORS - STRAIGHT - 17 CM STAINLESS STEEL DISPOSABLE METAL STERILE INSTRUMENTS

Common / Usual Name

Family :- Material:- Hardness:‐ Scissors / AISI 420 / 42 TO 46 HRC.


AB-030-12-DCode:-




IIAClass:-

6 Rule #:-

Single Use Surgically InvasiveJustification:-

Cutting Hard TissueIntended Use:-












JimcoIndustries





Since 1965

DA-007-001


Revision level: 01

Copy # SP/01




Jimco Code

AB-030-12-D

Customer Code

Material Type

AISI 410

AISI 304

AISI 420 42-46 Rev

isio

n No

1

2

3

4

5

Date Description

Type-Single Use

Product: Mayo scissors - straight- 17cm

FDAApproved

ISO13485

9001-2003Certified


Tolerance

xxx


5.00

xx 0.50-0.30

x 0.25-0.15

Drawn By:

Approved By

Q.A:Departmet

Managing Director


Phone: +92 52 3611253. Fax: +92 52 3611453

PLANFAMILY SCISSORS

170.00




JimcoIndustries




Revision level: 01

Copy # SP/01


STERILE SPENCER WELLS 13CM STRAIGHT STAINLESS STEEL - (DISPOSABLE METAL STERILE INSTRUMENTS)

Common / Usual Name



AC-127-02-D Code:-




IIAClass:-

6 Rule #:-


Holding tissue/ artery during surgery Intended Use:-

JI/CE/FCP2Reference To Manufacturing Procedure:-











JimcoIndustries





Since 1965

DA-007-001


Revision level: 01

Copy # SP/01



Jimco Code

AC-127-02-D

Customer Code

Material Type

AISI 410

AISI 304

AISI 420

40-44

Rev

isio

n No

1

2

3

4

5

Date Description

Type-Single Use

Product: Spencer wells forceps straight 13cm

FDAApproved

ISO13485

9001-2003Certified


Tolerance

xxx


5.00

xx 0.50-0.30

x 0.25-0.15

Drawn By:

Approved By

Q.A:Departmet

Managing Director


Phone: +92 52 3611253. Fax: +92 52 3611453



PLANFORCEPS


0.09 to 0.15 %


GRADE-410



JimcoIndustries




Revision level: 01

Copy # SP/01


Documents

SSinince ce 11969565 Part: First (A) Jimco Revision level: 01 · 2019-07-05 · approved, batch number is also indicated on the label and shifted to approved material/ in-process