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SET, SUTURE, s.u. instruments, sterile

https://unicat.msf.org/cat/product/18520
STD SSURSUTU1--

Valid Article

Former Code(s): SDRESUTU1-- SDRESSUS1--
The product is supplied (and stored) sterile, it must remain sterile until its use. Sterile = state of being free from all living microorganisms.
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.
H9008 - Single-use suture instruments
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.
IIa
In Europe, medical material that fulfills the definition of a medical device according to the MDR (Medical Device Regulation) is classified into 4 classes
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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SUTURE SET, disposable

Definition

Single use suture set for the first aid kit.

Specifications

Composition of the set:

  • 1 pair of plastic scissors with metal blades
  • 1 plastic needle holder with metal end
  • 1 forceps
  • 2 gauze swabs
  • 1 procedure field

Sterile, for single use

Packaging & Labelling

Unit sterile packaging in peel-open pack

MSF requirements

Single use suture set selected for the first aid kit. The first aid kit is mainly placed in ambulances or used for exploratory missions, where the means for sterilising a reusable suture set are not present.

Plastic instruments were preferred to steel instruments in order to make the difference with the reusable steel instruments, as they cannot be sterilized to allow reuse.

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