Sound,uterine,Martin,320mm

General Description:
Sound, uterine, Martin, 320 mm.

Intended use:
To measure and/or explore the depth or length of the uterus, cervix, and vagina.

Technical Specifications:
Static function instrument: uterine sound.
See Martin Catalogue no. 24 Ref: 32 586 32.
Malleable shaft graduated in cm.
Bulbous distal end, mounted on a handle.
Length: approx. 32 cm.
Material: Silver-coated copper with brass handle or 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: 40% 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

Compliance with safety & product performance standards:
ISO 7153-1:2016: Surgical instruments - Materials - Part 1: Metals.
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: Uterine sound, reusable (13644).
UMDNS code: Sounds, Uterine (13644).

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) uterine sound in a plastic bag.

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

Labelling on the primary packaging:
Name and/or trademark of the manufacturer.
Manufacturer's product reference.
Type of product and main characteristics.
Information for particular storage conditions (temperature, pressure , light, humidity, etc.), as appropriate (or equivalent harmonised symbol).
Information for handling, if applicable (or equivalent harmonised symbol).
Over packaging: Packaging unit
Labelling on the packaging unit: Labelling to be the same as primary packaging.
Extra information required: Number of units per box.

Any symbol used on the labelling should be in accordance of the ISO 15223- 1: 2016:
If the item has a CE marking (or equivalent), the CE logo (or equivalent) must be visible on the packaging.

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