General information
For injection of a local anaesthetic and for spinal anaesthesia. For taking spinal fluid samples.
Specifications
Components & materials: Cannula: stainless steel, without silicone.
Stylet: stainless steel, without silicone.
Base: polypropylene of polyamide.
Cap: rigid plastic.
Product description:
Needle, spinal, 25G (0.53 x 90mm) disposable, sterile.
Quincke bevel spinal needle.
Transparent hub, to allow easy visualization of cerebrospinal fluid (CSF).
Needle core hub with lock to keep the surface of needle bevel joint well.
External diameter expressed in Gauge and mm.
Length expressed in mmColour code/external diameter: Visible at the base of the spinal needle.
Components: Needle, stylet and sheath.
Material:
Stainless steel needle and stylet without silicone.
Clear ridged polycarbonate hub.
Protective plastic sheath.
Size selected: 25G (0.53 x 90mm) .
Disposable.
Sterile.
Initial sterilisation method: Ethylene oxide gas.
Instructions for use:
Sterile spinal needle that can be introduced into the subarachnoid space to withdraw cerebrospinal fluid (CSF) for diagnosis purpose, of for injecting local anaesthetic into the CSF for spinal anaesthesia (surgical purpose).
Must be used by qualified personnel only.
Safety process:
The spinal needle is for single use only.
Strict rules of asepsis must be followed when inserting spinal needle.
Supplied with:
Manufacturer's instruction for use.
Packaging and labelling:
Primary packaging: Unit of use.
One (1) spinal needle in an individual sterilised peel pack.
Secondary packaging: Protected unit.
One (1) box of 25 spinal needles.
Symbols used according ISO 15223
CE mark with Notified Body number
Includes multilingual user instructions: English, French and Spanish, others when available.
Regulatory & Conformity Requirements:
CE mark Comply to EU Council Directive 93/42/EEC (MDD) of EU Regulations 2017/745 (MDR) with valid EC Certificate and Declaration of Conformity for the CE mark is applicable.
US FDA 510(K) clearance
CE certificate available for Class IIa and above devices
Manufacturer’s Quality Management System is certified to ISO 13485 : 2016
Classification:
Classified under EU MDR 2017/745 as Class III device
Safety & product Standards:
Must comply with the following standards:
EN-ISO 20594-1: Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements
ISO 80369-7 : Small-bore connectors for liquids and gases in healthcare applications — Part 7: Connectors for intravascular of hypodermic applications
EN-ISO 7864-1: Sterile hypodermic needles for single use
ISO 11607-1:2007 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
Environmental requirements:
Use of other polymer instead of PVC
| Pack Size | Avg. Price |
|---|---|
| Pack of 1 | $0.23 |
| Pack of 25 | $12.87 |
| Pack of 50 | $21.84 |
