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Forceps, Dressing, Standard Pattern, 12.7 cm - 1002012

Product ID: ITM-1002012
generic
GENERAL DESCRIPTION
Forceps, dressing, standard, 127 mm, straight.

INTENDED USE
Dressing forceps for gripping, dissecting tissue and coagulation of vessels.
Used in surgery and nursing activities.
Forceps without teeth are used for dissecting delicate tissues.

PRODUCT DESCRIPTION / TECHNICAL SPECIFICATIONS
Pressure force instrument: dissecting forceps, springy
See Martin Catalogue no. 24 Ref: 12 140 25.
Straight without teeth.
Flexible arms.
Serrated jaws
Length:12.7cm.
Material: Martensitic steel (quenched, magnetic steel).
Martensitic steel composition: 0.20% carbon, 13% chromium.
Reusable.

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

Instructions for use:
Used for dressing in the abdominal area / swabbing of vagina in preparation for surgical intervention. Also used as serving forceps (used with jar for forceps)
This item must be cleaned, disinfected after each use, and sterilised in a steam steriliser.

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:
ISO 7153-1:2016: Surgical instruments - Materials - Part 1: Metals.
ISO 7151:1988: Surgical instruments - Non-cutting, articulated instruments - General requirements and test methods.
ISO 13402:1995: Surgical and dental hand instruments - Determination of resistance against autoclaving, corrosion and thermal exposure.
ISO 17664:2017: Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices.
ISO 14971:2007 Medical devices - Application of risk management to medical devices.

ISO 7153-1:1991 Surgical instruments --Metallic materials --Part 1: Stainless steel

Environmental conditions:
Storage and transport conditions: 5°C to 40°C.
Humidity: 30% RH to 70% RH.

Pack SizeAvg. Price
Pack of 1$1.10