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(scalpel nº 3 and 7) BLADE, s.u., sterile, nº 11, 01-22-11

https://unicat.msf.org/cat/product/14252
STD ESURSCALB11

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.
V010102 - Scalpels without safety systems, single-use
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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Scalpel blade, disposable

Definition

A sterile interchangeable device designed to mount a compatible handle and function as the cutting edge of a scalpel. The device is made of high-grade stainless steel alloy and is used as a surgical instrument to cut and dissect tissues.

Specifications

Technical specifications

  • Sterile, single use item
  • Blades are manufactured with a corresponding fitment size so that they fit on only handles with the same fitment.
  • Material: martensitic steel
  • Hardness: 50 to 58 HRC (Hardness Rockwell Scale C)
  • The number indicates the shape of the blade
  • Length of the blade :
    • Blade nr 11 : 40 mm
    • Blade nr 12 : 38 mm
    • Blade nr 15 : 38 mm
    • Blade nr 22 : 57 mm
  • Blade No. 11 - is an elongated triangular blade sharpened along the hypotenuse edge and with a strong pointed tip making it ideal for stab incisions. The No.11 blades fit handles 3, 3L, 3 Graduated, 5B, 7, 9, B3 and B3L.
  • Blade No. 12 - is a small, pointed, crescent shaped blade sharpened along the inside edge of the curve. It is sometimes utilised as a suture cutter. The No.12 fits handles 3, 3L, 3 Graduated, 5B, 7, 9, B3 and B3L.
  • Blade No. 15 - has a small curved cutting edge and is the most popular blade shape ideal for making short and precise incisions. The No.15 fits handles 3, 3L, 3 Graduated, 5B, 7, 9, B3 and B3L.
  • Blade No.22 is a large version of the No.10 blade with a curved cutting edge and an unsharpened back edge. No.22 fits handles 4, 4L, 4 Graduated & 6B

Packaging & Labelling

Aluminium-laminated individual sterile packaging.

Packaged per 100.

Instructions for use

Single use only

To prevent any risk of injury, use forceps to fit the blade on the handle and to remove it.

When removing a blade form the protective packet make sure it is not dropped into a metal bowl or container as this can reduce the initial keenness of the cutting edge even before it is fitted to the handle. If you have to use forceps or needle holders to remove the blade from its protective packet ensure that you do not grip the blade across the cutting edge.

    Keep a sufficient stock.

    Waste management

    Immediately after use, dispose of the soiled blade into a sharps container (see related articles below).

    (Cf Public Health Engineering In Precarious Situations, MSF, 2010, Chapter 6)

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