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Forceps, intestinal, clamp, Doyen, 23cm, straight - 1000278

Product ID: ITM-1000278
generic
Intended purpose of use: Used for atraumatic clamping/occlusion of a section intestine while suturing, resection of anastomosis.

Product description: Doyen Forceps are a lightweight, non-crushing clamp. Commonly used to grasp large organs such as lungs, of intestines, the Doyen forceps have long jaws and shorter shanks.
Intestinal clamp, Doyen, straight, used for transverse, non-crushing occlusion of a section intestine while suturing an anastomosis.
Material: Martensitic stainless steel (quenched, magnetic steel) composition: 0.20% carbon; 13% chromium.
Curved.
Jaws very springy and soft.
Features: Non traumatic
Occlusion: The form and mechanical action must permit precise closing.
Multiple ratchet
Box lock.
Highly impact resistant.
Length: approx. 230 mm
Supplied non sterile, Hygienically packed for medical use after sterilization.
Reusable: Can withstand repeated reprocessing including steam sterilization, including manual brushing and the use of disinfectant chemicals

Supplied with:
Manufacturer's instruction for use

Instructions for use:
Used for transverse, non-crushing occlusion of a section intestine while suturing an anastomosis. The jaws must be meticulously cleaned.
This item must be cleaned, disinfected after each use, and sterilised in a steam steriliser.

Packaging & Labelling:
One (1) forceps in a plastic bag.
Symbols used according ISO 15223
CE mark

Regulatory & Conformity Requirements:
CE mark Comply to EU Council Directive 93/42/EEC (MDD) of EU Regulations 2017/745 (MDR) with valid EC Certificate and Declaration of Conformity for the CE mark is applicable.


US FDA 510(K) clearance

CE certificate available for Class IIa and above devices
Manufacturer’s Quality Management System is certified to ISO 13485 : 2016

Classification:
Classified under EU MDR 2017/745 as Class I device


Safety & product Standards:
Must comply with the following standards (as per latest revisions of the standards):
ISO 7153-1:1991
ISO 7151:1988
ISO 17664:2004
ISO 13402:1995

Environmental: ISO 14001

Special instructions: Refer WHO guidance document 'Decontamination and reprocessing of medical devices for health-care facilities World Health Organization (‎2016)'‎ for reprocessing of reusable medical devices
Supplied with:
Manufacturer's instruction for use.

Instructions for use:
Used for transverse, non-crushing occlusion of a section intestine while suturing an anastomosis.
This item must be cleaned, disinfected after each use, and sterilised in a steam steriliser.

Packaging & Labelling:
One (1) forceps in a plastic bag.
Symbols used according ISO 15223
CE mark
Labelling as per regulations applied to the device. Shall include name of the device, name and address of the manufacturer, product code of manufacturers reference number etc.


Special instructions: Refer WHO guidance document 'Decontamination and reprocessing of medical devices for health-care facilities World Health Organization (‎2016)'‎ for reprocessing of reusable medical devices

Pack SizeAvg. Price
Pack of 1$7.68