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SPINAL NEEDLE, ANAESTHESIA, NRFit, pencil, 25Gx90 mm, guide

https://unicat.msf.org/cat/product/80091
STD SINSNSNRP25I

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, NRFit, pencil

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 80369-1, 2018, edition 2, Small-bore connectors for liquids and gases in healthcare applications - Part 1: General requirements
  • ISO 80369-6, 2016, edition 1, Small bore connectors for liquids and gases in healthcare applications Part 6: Connectors for neuraxial applications

Quality Standards Comment

ISO 80369-6:2016 specifies requirements for small-bore connectors intended to be used for connections in neuraxial applications. Neuraxial applications involve the use of medical devices intended to administer medications to neuraxial sites, wound infiltration anaesthesia delivery, and other regional anaesthesia procedures or to monitor or remove cerebro-spinal fluid for therapeutic or diagnostic purposes.

NOTE 1 Sites for the neuraxial application include the spine, intrathecal or subarachnoid space, ventricles of the brain, and the epi-, extra-, or peri-dural space. Neuraxial application anaesthetics can be administered regionally affecting a large part of the body, such as a limb, and include plexus blocks, such as the branchial plexus blocks or single nerve blocks. Neuraxial application procedures include continuous infusion of wounds with local anaesthetic agents.

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 NRFit 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 colour code corresponding to the external diameter of the needle: orange for 25G, black for 27G
  • INTRODUCTION GUIDE: 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 (90 mm and 120 mm long) and 2 diameters (25G and 27G)

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.

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