Dilators,uter,Hegar,d-e,3-4to17-18mm

General Description:
Dilator, uterine, Hegar, double-ended, 3 - 4 to 17 - 18 mm.

Intended use:
To dilate the cervix of the uterus in order to make room for the insertion of instruments.

Technical Specifications:
Static function instrument: uterine dilator.
See Martin Catalogue no. 24 Ref: 32 430 82.
Provided in sets of 8 (16 dilators).
Sizes: 3 - 4 mm to 17 - 18 mm diameter in canvas roll.
Double ended with round, smooth, atraumatic ends.
Material: Austenitic steel (non quenched, non magnetic steel).
Austenitic steel composition: 16 - 18 % chromium; 10-14 % 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

Classification:
EU Medical Devices Directive 93/42/ECC, Class I

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: Fixed-diameter cervical dilator, reusable (11266).
UMDNS code: Dilators, Uterine (11266).

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) dilator in a plastic bag.

Secondary packaging:
Protected unit. 8 sets (16 dilators) in a canvas roll.

Component of a kit:
S9910002 - Surg. inst., curettage /SET.