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(Stimuplex HNS12) NEEDLE echogenic Luer 22Gx35mm 4892503-01

https://unicat.msf.org/cat/product/79901
STD EANENESC1223

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.
A010302 - Plexus block needles and kits
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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(nerve stimulator Stimuplex) NEEDLE echogenic

Definition

Hollow needle for electrical stimulation of peripheral nerves that facilitates the atraumatic performance of regional anaesthesia blocks.

The needles must be used with the nerve stimulator.

This technique allows the localisation of nerve plexuses and peripheral nerves with a motor component. During injection of local anaesthetics, the immediate simultaneous disappearance of the motor response helps to confirm the right position of the needle.

Synonym

stimulation cannula

Specifications

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Quality standards

ISO 20698, 2018, edition 1, Catheter systems for neuraxial application — Sterile and single-use catheters and accessories

Technical specifications

  • NEEDLE
    • atraumatic 30° facet bevel
    • insulated transparent coating on the whole length
    • echogenic 360° X-pattern combined with a clear coating, reflects ultrasound waves back to the probe
    • graduations every centimeter
    • additional markings
      • each 5 cm: 1 broad ring mark
      • each 10 cm: 2 broad ring marks
    • with protective cap
  • INJECTION TUBE (= EXTENSION SET)
    • transparent, 50 cm long, DEHP-free PVC
    • distal end: female Luer Lock connector with stopper
  • CONNECTING CABLE
    • cable for connecting the nerve stimulator: Stimuplex HNS12
  • Sterile, for single use

Comes in 3 sizes:

  • 20 G = Ø 0.9 mm, length 100 mm
  • 22 G = Ø 0.7 mm, length 50 mm
  • 22 G = Ø 0.7 mm, length 35mm

Packaging & Labelling

Unit sterile packaging in peel-open pack. Box of 25.

Instructions for use

See user manual (Stimuplex HNS12)

Precautions for Use

To prevent accidental needlestick injuries, never recap the needle after use.

MSF requirements

The Stimulplex HNS12 needles should only be used with the selected nerve stimulator Stimuplex HNS 12.

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