GENERAL DESCRIPTION
Retractor, double-ended, Farabeuf, 120 mm, pair.
INTENDED USE
To retract skin, fatty tissue, muscles of viscera during superficial surgery.
Suprapubic means that the surgery is done through an incision in your lower abdomen, above your pubic bone. An incision is made in your bladder, and the centre of your prostate gland is removed.
PRODUCT DESCRIPTION / TECHNICAL SPECIFICATIONS
Static function instrument: retractor with handle.
See Martin Catalogue no. 24 Ref: 15 663 00.
Double-ended retractor.
Slightly curved blade at each end.
Smooth blunt blades with slight upward lip at the end.
Small: approx. 12 cm.
Material: Austenitic steel (non-quenched, non-magnetic steel).
Austenitic steel composition: 18 to 20% chromium, 8 to 10% nickel.
Supplied in pairs.
Reusable.
Packaging and labelling:
Unit presentation: individually, in protective packaging.
The following should appear on the packaging:
- Designation of the instrument.
- Name and address and supplier (manufacturer)
Symbols used according ISO 15223
CE Mark
Instructions for use:
To retract skin, fatty tissue, muscles of viscera during superficial surgery.
This item must be cleaned, disinfected after each use, and sterilised in a steam steriliser.
Used to grip soft tissue
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.
Environmental conditions:
Storage and transport conditions: 1°C to 30°C.
Humidity: 30% RH to 70% RH.
Retractor, double-ended, Farabeuf, 120 mm, pair.
INTENDED USE
To retract skin, fatty tissue, muscles of viscera during superficial surgery.
Suprapubic means that the surgery is done through an incision in your lower abdomen, above your pubic bone. An incision is made in your bladder, and the centre of your prostate gland is removed.
PRODUCT DESCRIPTION / TECHNICAL SPECIFICATIONS
Static function instrument: retractor with handle.
See Martin Catalogue no. 24 Ref: 15 663 00.
Double-ended retractor.
Slightly curved blade at each end.
Smooth blunt blades with slight upward lip at the end.
Small: approx. 12 cm.
Material: Austenitic steel (non-quenched, non-magnetic steel).
Austenitic steel composition: 18 to 20% chromium, 8 to 10% nickel.
Supplied in pairs.
Reusable.
Packaging and labelling:
Unit presentation: individually, in protective packaging.
The following should appear on the packaging:
- Designation of the instrument.
- Name and address and supplier (manufacturer)
Symbols used according ISO 15223
CE Mark
Instructions for use:
To retract skin, fatty tissue, muscles of viscera during superficial surgery.
This item must be cleaned, disinfected after each use, and sterilised in a steam steriliser.
Used to grip soft tissue
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.
Environmental conditions:
Storage and transport conditions: 1°C to 30°C.
Humidity: 30% RH to 70% RH.
| Pack Size | Avg. Price |
|---|---|
| Pack of 1 | $6.60 |
