Retractor,vaginal,Doyen,45x85mm

General Description:
Retractor, vaginal, Doyen, 45 x 85 mm.

Intended use:
To expose the vaginal cavity.

Technical Specifications:
Static function instrument: vaginal retractor with handle.
See Martin Catalogue no. 24 Ref: 32 250 02.
Blunt lateral edges.
Blade length: approx. 85 mm.
Blade width: approx. 45 mm.
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 (13392)

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.

Labelling on the primary packaging:
Name and/or trademark of the manufacturer.
Manufacturer's product reference.
Type of product and main characteristics.
Information for particular storage conditions (temperature, pressure, light, humidity, etc.), as appropriate (or equivalent harmonised symbol).
Information for handling, if applicable (or equivalent harmonised symbol).
Over packaging: Packaging unit
Labelling on the packaging unit: Labelling to be the same as primary packaging.
Extra information required: Number of units per box.

Any symbol used on the labelling should be in accordance of the ISO 15223- 1: 2016:
If the item has a CE marking (or equivalent), the CE logo (or equivalent) must be visible on the packaging.

Component of a kit:
S9910002 - Surg. inst., curettage /SET.
S9910006 - Surg. inst., exam/sut. vaginal/cervical /SET.