S0745000

Scalpel handle,no.3


Scalpel handle no. 3.
Indicative Price 0.86 USD
Disclaimer: The images shown are for illustration purposes only and may not be an exact representation of the product. “No Generic Photo Available" means that there is not an image available for this product.

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.
Related Products