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SPINAL NEEDLE, ANAESTHESIA, Luer, pencil, 25G x 120mm, guide

https://unicat.msf.org/cat/product/70157
STD SINSNESAP25IL

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.
A01030101 - Spinal anaesthesia 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.
III
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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SPINAL NEEDLE, ANAESTHESIA, pencil point

Definition

Hollow needle which is introduced into the subarachnoid space at the lumbar vertebral level to inject a local anaesthetic into the cerebrospinal fluid.

Synonym

Whitacre point spinal needle, pencil point spinal needle

Specifications

Image

Quality standards

  • ISO 7864, 2016, edition 4, (confirmed 2021) Sterile hypodermic needles for single use - Requirements and test methods
  • ISO 6009, 2016, edition 4, (confirmed 2021) Hypodermic needles for single use - Colour coding for identification

Technical specifications

  • NEEDLE
    • Stainless steel, not coated with silicone
    • Pencil tip (Whitacre): designed to separate the dural fibres instead of cutting them
    • Translucent hub to observe CSF reflux with female Luer connector
    • Notch on the hub, indicating the direction of the bevelled tip
    • Protective sheath
  • STYLET
    • stainless steel, not coated with silicone
    • closely fitted to the needle lumen
    • hub with standardized colour code corresponding to the external diameter of the needle: orange for 25G
  • INTRODUCTION GUIDE for the 25 G needle: the spinal needle is inserted through this introducer to reduce the risks of kinking
    • stainless steel rod, not coated with silicone
    • size: G 20: 0.9 mm x 32 - 38 mm
    • hub
  • Sterile, for single use

Comes in 2 lengths:

  • SINSNESAP25I = 88 - 90 mm long
  • SINSNESAP25IL = +/- 120 mm long and is intended for obese patients​

Packaging & Labelling

Unit sterile packaging in peel-open pack.

Box of 10 or 25 pieces.

Instructions for use

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Precautions for Use

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

MSF requirements

The 22G rachi needles have been removed from the standard list as their use is associated with high prevalence of CSF leakage following dural puncture during spinal anaesthesia, resulting in high rates of post dural puncture headaches, particularly in obstetrics. The main size to be used is 25G and available. There is an over-use of the 22G needle in the field, although it can be useful in some cases of elderly patients with calcified intervertebral spaces, the overall risks outweigh this potential benefit.

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