Probe,double-ended,145mm

General Description:
Probe, double-ended, 145 mm.

Intended use:
To explore a surgical wound or to explore and/or dilate strictures inside a fistula.

Technical Specifications:
Probe / dilator, straight.
See Martin Catalogue no. 24 Ref: 16 100 14.
Blunt bulbous shaped ends.
Diameter of the ends: approx. 2 mm.
Length: approx. 145 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: ENT probe, reusable (33433)
UMDNS code: Probes, Other (15237)

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) probe in a plastic bag.

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

Component of a kit:
S9910001 - Surg. inst., basic surgery /SET.
S9910004 - Surg. inst., suture /SET.