Forceps,uterine,Duplay,280mm,cvd

General Description:
Forceps, uterine, tenaculum, Duplay, 280 mm, curved.

Intended use:
For gripping and immobilisation of thick tissue (uterine traction forceps).

Technical Specifications:
Pressure force instrument: gripping forceps, springy.
See Martin Catalogue no. 24 Ref: 32 645 28.
Uterine traction forceps, vulsellum / tenaculum, double curved.
Hard ratchet, lockable.
Length: 28 cm.
Material: Martensitic steel (quenched, magnetic steel).
Martensitic steel composition: 0-15-0.20% carbon, 12-13% chromium.
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

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: Surgical soft-tissue manipulation forceps, scissors-like, reusable (62468)
UMDNS code: Forceps, Tissue (11797)

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) forceps in a plastic bag.

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

Component of a kit:
S9910000 - Surg. inst., abdominal /SET.