Scoop,uterine,Simon,12mm,sharp

General Description:
Scoop, uterine, Simon, 12 mm, sharp.

Intended use:
For removal of retained products of conception from inside the uterus during gynaecological procedures.

Technical Specifications:
See Martin Catalogue Ref: 32 900 05.
Uterine scoop.
Shank type: Rigid.
Blade shape: Oval form of a spoon.
Blade edge type: Sharp
Material: Martensitic steel (quenched, magnetic steel).
Martensitic steel composition: 0.16-0.40 % carbon; 14 % chromium.
Handle: Austenitic steel
Length: Shaft 25 cm.
Width: Spoon 12 mm.
Reusable.

Environmental conditions:
Storage and transport conditions: 5°C to 40°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 to safety & product 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.

Nomenclature:
GMDN code: Intrauterine scoop (46870).
UMDNS code: Scoops (13508).

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) scoop in a plastic bag.

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

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