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(dermatome, Humby/Watson) BLADE, sterile, s.u.

https://unicat.msf.org/cat/product/14008
STD ESURDERH1BD

Valid Article

Former Code(s): -X
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.
V0103 - Blades, single-use - not included in other classes
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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(dermatome, Humby/Watson) BLADE

Definition

A surgical cutting device that is designed to be mounted into a dermatome and used to provide the cutting edge for the harvesting of skin grafts or excision of small skin lesions.

Specifications

Technical specifications

  • Rectangular blade: 10 cm x 1.2 mm
  • 2 holes allowing to screw it on the dermatome
  • Bevelled on one side, sharp cutting
  • Material: martensitic steel
  • Sterile, for single use

Packaging & Labelling

Individual sterile packaging

Packed per 10

Instructions for use

Single use only (risk of contamination).

Keep a sufficient stock.

The blades are the same for the Watson dermatome and for the Humby dermatome that was previously used.

Waste management

Immediately after use, dispose of the soiled blade into a sealed container. Get rid of in a sharp pit.

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