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SKIN STAPLER, 35 regular staples , sterile, s.u.

https://msf.oodin.sh/cat/product/69181
STD SSUTSKST35R

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.
H02010101 - Skin staplers, 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
CT3+
Thermosensitive codes are defined for storage and transportation temperature requirements of the products.
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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SKIN STAPLER, + staples, sterile, s.u.

Definition

A sterile hand-held surgical instrument designed for the application of skin staples to approximate free edges of skin from an incision or wound. This device, often pistol-like in design, is typically loaded with staples and is intended to mechanically deliver staples with manual power. This is a single-use device.

Specifications

Image

Technical specifications

STAPLER

  • 35 rectangular staples are loaded in the stapler
  • Indication of remaining staples
  • Sterile, for single use

STAPLES

The construction of the staple is a design that folds up and ultimately makes a box shaped 'stitch' which holds the skin edges together but is slightly elevated from the natural level.

  • Material: stainless steel (austenitic low carbon steel containing +/-3% molybdenum) or titanium
  • Size: slight variations occur according to manufacturer
  • Thickness: 0.5 – 0.6 mm
  • Staple depth: 3.5 – 4.9 mm
  • Backspan:
    • Wide : 6.4 – 7.2 mm
    • Regular : 5.0 – 5.9 mm

See picture

  • 1 = original staple
  • 2 = formed staple
  • 3 = range of forming

Packaging & Labelling

Unit sterile packaging in peel open tray pack

Instructions for use

  • Hold the skin edges together evenly by using a forceps.
  • Place the centre mark of the stapler at the middle of the two skin edges.
  • Squeeze the handle completely. Incompleteness of squeezing handle may cause incomplete forming of staple or improper stapling. Repeat above steps, while maintain same distance between each placed staples until the incision is closed. Any malformed staples should be removed and replaced with a new staple.
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Precautions for Use

Make sure to press the handle COMPLETELY on the stapler in order to release the staple, otherwise the staple is not completely liberated and may block the next ones.

Storage

Protect from sunlight ‐ Protect from humidity

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