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(FastClix lancing device) LANCET,30G,preloaded,6lancets/drum

https://msf.oodin.sh/cat/product/98187
STD STSSLAND101-

Valid Article

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.
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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6 LANCETS DRUM, 30G, preloaded

Definition

Drum containing 6 lancets, to be inserted in the Accu-Check FastClix lancing device. It allows you to draw blood 6 times, each time using a new sterile lancet. Once all six lancets have been used, the lancet drum must be changed.

These drums are for individual use at home.

Specifications

  • To use with lancing device FastClix (included in the kit of Glucometer Accu-Check from Roche Diabetes Care GmbH)
  • Drum with 6 pre-loaded lancets
  • 30G
  • Tapered, three-facet ground needle point
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Instructions for use

Single use only.

MSF requirements

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