Spatula,abdo,malleable,250mm

General Description:
Spatula, abdominal, malleable, 250 mm.

Intended use:
To hold open fatty tissue, muscle or viscera after an abdominal incision.

Technical Specifications:
Static function instrument: depressor spatula.
See Martin Catalogue no. 24, Ref: 159 73 25.
Rectangular with rounded ends.
Malleable: can be bent according to the operative field to be kept open.
Size approx. 25 x 250 mm.
Material: Austenitic steel (non-quenched, non-magnetic steel).
Austenitic steel composition: 16-18% chromium, 8-14% nickel, 2-3% molybdenum.
Reusable.

Environmental conditions:
Storage and transport conditions: 1°C to 30°C.
Humidity: 30% RH to 70% RH.

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

Regulation & conformity requirements:
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: Abdominal/intestinal spatula (36293)
UMDNS code: Spatulas, Other (15249)

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) spatula in a plastic bag.

Secondary packaging: Protected unit.
Ten (10) spatulas in a box.

Component of a kit:
S9910000 - Surg. inst., abdominal /SET.