Retractor,vaginal,Auvard,38x80mm

General Description:
Retractor, vaginal, Auvard, 38 x 80 mm.

Intended use:
To spread and open the posterior wall of the vagina to visualize the uterine cervix.

Technical Specifications:
Static function instrument: vaginal speculum.
See Martin Catalogue no. 24 Ref: 32 310 22.
With weight which fits on the shank of the blade.
Blade width: approx. 38 mm.
Blade length: approx. 80 mm blade.
Total length: approx. 24 cm.
Material: Austenitic steel (non-quenched, non-magnetic steel).
Austenitic steel composition: 18 to 20% chromium, 8 to 10% nickel.
Reusable.

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

Quality Management System:
ISO 13485:2016: Medical devices - Quality management systems

Classification:
EU Medical Devices Directive 93/42/ECC, Class I

Compliance to safety & product performance 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.

Nomenclature:
GMDN code: Hand-held surgical retractor, reusable (45918)
UMDNS code: Retractors Vaginal (1339)

Safety process:
This item must be cleaned, disinfected after each use, and sterilised in a steam steriliser.

Packaging and labelling:
Primary packaging: Unit of use
One (1) retractor in a plastic bag.

Component of a kit:
S9910002 - Surg. inst., curettage /SET.