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ORTHOPAEDIC BONE WIRE, soft, coil 10m, 0.5mm 76-01-05

https://unicat.msf.org/cat/product/14330
STD ESURWIRE05-

Valid Article

Former Code(s): -X
Single use
A single-use device, also referred to as a disposable device, is intended for use on one patient during a single procedure. It is not intended to be reprocessed (i.e., cleaned and disinfected or sterilized).
CE marking: declaration that the product meets EU standards for health, safety, and environmental protection. The CE marking indicates that the product may be sold freely in any part of the European Economic Area, regardless of its country of origin.
P091203 - Bone fixation wires
European Medical Device Nomenclature (EMDN) is the nomenclature of use by manufacturers when registering their medical devices in the EUDAMED database. EMDN is characterised by its alphanumeric structure that is established in a seven-level hierarchical tree.
IIb
In Europe, medical material that fulfills the definition of a medical device according to the MDR (Medical Device Regulation) is classified into 4 classes
The product is part of at least one Kit. A kit is a collection of products (medical and/or logistic) that are needed for a certain intervention in emergency. The choice and quantity of the articles reflects the MSF protocols for this specific situation. The use of Kits allows to start an intervention without a detailed evaluation.
OC subscriptions: included in supply or field order tools (e.g. UniField)
SC subscriptions: included in supply or field tools
OC validations: approved for procurement and use by an OC for international or local orders specifying context and activity in Medical Standard Lists (MSL)

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Orthopaedic bone wire

Definition

A device used for the fixation of bone fractures. It is made of malleable metallic material and may be used as a cerclage wire to aid bone fixation.

Synonym

orthopaedic bone wire, cerclage fixation

Specifications

Quality standards

ISO 5832-1, 2016, edition 5, Implants for surgery - Metallic materials - Part 1: Wrought stainless steel

Technical specifications

  • Soft wire
  • Diameter: 3 sizes are selected: 0.5 mm / 1 mm / 2 mm
  • Length: coil of 10 m
  • Material: austenitic steel

Packaging & Labelling

Unit packaging = 1 roll

Instructions for use

This is a single use device.

MSF requirements

Part of the technical arsenal of orthopaedic surgeons.

Orthopedic (Cerclage) Wire used to hold body tissues together after an injury or surgery.

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