Scalpel handle,no.3

General Description:
Scalpel handle no. 3.

Intended use:
To hold compatible blade for surgical incisions.
To be used with: S0746010: Scalpel blade no. 10 and S0746110: Scalpel blade no. 11.

Technical Specifications:
Bistoury handle for interchangeable blade.
The number indicates the characteristic of the distal end and therefore the choice of blade.
See Martin Catalogue no. 24 Ref: 10 130 03.
Length: approx. 13.5 cm.
Material: Austenitic steel (non-quenched, non-magnetic steel).
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 7740:1985: Instruments for surgery - Scalpels with detachable blades - Fitting dimensions.
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: Scalpel handle, reusable (12235)
UMDNS code: Knife Handles (12235)

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) scalpel in a plastic bag.

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

Related products:
If required, the following items should be ordered separately:
S0746010 - Scalpel blade, ster, disp, no.10.
S0746110 - Scalpel blade, ster, disp, no.11.