Manufacturer , Exporter & Importers of Surgical, Dental, Rehabilitation & Sterile Disposable Instruments J i mc o I ndustr i es R Since 1965 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 Technical Information/ Specification # JI/CE/SDI/A Part: First (A) Revision level: 01 Copy # 01 Page. # 3 Since 1965 Since 1965 Jimco Industries INTRODUCTION This document considers the requirements of technical documentation/ Device Master Record/ Product Specifications to satisfy the applicable requirements of Medical Device Directive number 93/42/EEC as amended up to Directive 2007/47/EC and the applicable clauses of ISO 13485: 2003, Good Manufacturing Practice (GMP)/Quality System Regulation (QSR) and other applicable international standards. DEVICE SPECIFICATION /DATA SHEET
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Jimc o I ndustr iesManufacturer , Exporter & Importers of Surgical, Dental, Rehabilitation & Sterile Disposable Instruments Jimco IndustriesR Since 1965 4.0 Name and Address of the
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5.1 Manufacturer: Jimco Industries, (Same as above)
4-Km, Aimen Abad Road,
Near Akbar Abad Chowk, Sialkot, Pakistan
Technical Information/Specification # JI/CE/SDI/A
Part: First (A)
Revision level: 01
Copy # 01
Page. # 3
Since 1965Since 1965
JimcoIndustries
INTRODUCTION
This document considers the requirements of technical documentation/ Device Master Record/ Product Specifications to satisfy the applicable requirements of Medical Device Directive number 93/42/EEC as amended up to Directive 2007/47/EC and the applicable clauses of ISO 13485: 2003, Good Manufacturing Practice (GMP)/Quality System Regulation (QSR) and other applicable international standards.
DEVICE SPECIFICATION /DATA SHEET
Manufacturer , Exporter & Importers of
Surgical, Dental, Rehabilitation &
Sterile Disposable Instruments
J imco I n d u s t r i e sR
Since 1965
Class:- Rule #:- Justification IIA 6 Single use Surgically
invasive transient use
NUMBER OF DEVICES SPECIFICATION:- 07-
FAMILY:- DRESSING & TISSUE FORCEPS JUSTIFICATION:- SINGLE USE SURGICALLY INVASIVE TRANSIENT USE
BRIEF INTENDED USE:- SEE BELOW COLUMN FOR EACH DECEIVE.
Technical Information/Specification # JI/CE/SDI/A
Part: First (A)
Revision level: 01
Copy # 01
Page. # 4
Since 1965Since 1965
JimcoIndustries
Common / Usual NameArt NumbersClassification & relevant rule Intended use
(brief description of the devices)
Reference to Manufacturing
procedure/ MethodRule# Class Justification
6 Iia JI/CE/TW1Single Use Standard Dressing Tissue forceps
straight 13cm Made of stainless steel of Grade- 410
Iia
IIa
IIa
6
6
6
6
6
IIa
IIa
JI/CE/TW1
JI/CE/TW1
JI/CE/TW1
JI/CE/TW1
JI/CE/TW1
AD-100-14-D
AD-110-14-D
AD-158-20-D
AD-120-10-D
AD-140-10-D
Single Use Standard Dressing Tissue forceps straight 1x2 teeth 13cm
Made of stainless steel of Grade- 410
Single Use Standard Dressing Tissue forceps straight 16cm Made of stainless steel of Grade- 410
AD-171-15-D
AD-323-14-D
Single Use Adson tissue forceps 1x2 teeth straight 12cm Made of stainless steel of Grade- 410
Single Use Adson tissue forceps - straight- 12cm Made of stainless steel of Grade- 410
Single Use McIndoe dissecting forceps straight 15cm
Made of stainless steel of Grade- 410
Single Use Splinter plain forceps 12,5cm Made of stainless steel of Grade- 410
6 IIa JI/CE/TW1Single use Surgicallyinvasive transient use
holding of dressing,swabs,tissue;
insert/ablate foreign objects
holding of dressing,swabs,tissue;
insert/ablate foreign objects
holding of dressing,swabs,tissue;
insert/ablate foreign objects
holding of dressing,swabs,tissue;
insert/ablate foreign objects
retraction, grasping,or dissection of tissue
during surgicalprocedures. Holding and
moving of dressings,swabs. holding of dressing, swabs,
tissue; insert/ablate foreign objects
Single use Surgicallyinvasive transient use
Single use Surgicallyinvasive transient use
Single use Surgicallyinvasive transient use
Single use Surgicallyinvasive transient use
Single use Surgicallyinvasive transient use
Single use Surgicallyinvasive transient use
DEVICE SPECIFICATION /DATA SHEET
STERILE STANDARD DRESSING TISSUE FORCE STRAIGHT 13CM STAINLESS STEEL - (DISPOSABLE METAL STERILE INSTRUMENTS)
SINGLE USE SURGICALLY INVASIVE TRANSIENT USEJustification:-
retraction, grasping, or dissection of tissue during surgical procedures. Holding and moving of dressings, swabs. holding of dressing, swabs, tissue; insert/ablate foreign objectsIntended Use:-
JI/CE/TW1Reference To Manufacturing Procedure:-
Ce /stainless Steel / Sign Of Single Use / On Customer RequestMarking:- ( SKU / LOT # )
SINGLE USE SURGICALLY INVASIVE TRANSIENT USEJustification:-
retraction, grasping, or dissection of tissue during surgical procedures. Holding and moving of dressings, swabs. holding of dressing, swabs, tissue; insert/ablate foreign objectsIntended Use:-
JI/CE/TW1Reference To Manufacturing Procedure:-
Ce /stainless Steel / Sign Of Single Use / On Customer RequestMarking:- ( SKU / LOT # )
SINGLE USE SURGICALLY INVASIVE TRANSIENT USEJustification:-
retraction, grasping, or dissection of tissue during surgical procedures. Holding and moving of dressings, swabs. holding of dressing, swabs, tissue; insert/ablate foreign objectsIntended Use:-
JI/CE/TW1Reference To Manufacturing Procedure:-
Ce /stainless Steel / Sign Of Single Use / On Customer RequestMarking:- ( SKU / LOT # )