Intended purpose of use: For injection of a local anaesthetic and for spinal anaesthesia and For taking spinal fluid samples.
Product description:
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).
Quincke bevel spinal needle.
Components & materials:
Cannula: stainless steel, without silicone coating.
Stylet: stainless steel, without silicone coating.
Base: polypropylene of polyamide.
Cap: rigid plastic.
-The Cannula is cylindrical; at one end it has a base that is either opaque of translucent, and at the other end a short bevelled tip, called a "Quinck".
This short spine bevelled tip, used around the spine, is designed to separate the dural fibres rather than cutting them, thus reducing damage and the loss of cerebrospinal fluid.
- The stylet is the same length as the tube; it fits properly into the needle lumen and indicates the bevel position of the needle.
- The base allows the needle to be connected to a syringe and is formed by a conical female Luer connection.
- hub (base) with standardized colour code corresponding to the external diameter of the needle.
-Transparent hub, to allow easy visualization of cerebrospinal fluid (CSF).
External diameter expressed in Gauge and mm.
Length expressed in mm.
Size selected: 22G (0.70 x 90mm) black, for spinal anaesthesia, adults.
Sterile and single use.
Initial sterilisation method: Ethylene oxide gas.
Shelf life to be included.
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. To prevent accidental needlestick injuries, never recap the needle after use.
Supplied with:
Manufacturer's instruction for use. Indications for use, warnings, storage conditions, disposal instructions etc.
Packaging and labelling: Shall be as per regulations applied to the device.
Primary packaging: Unit of use.
One (1) spinal needle in an individual sterilised peel pack.
Secondary packaging: Protected unit.
One (1) box of 50 spinal needles.
Symbols used according ISO 15223.
CE mark with Notified Body number.
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 (must comply to latest revisions of the standards):
ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.
ISO 7864:1993: Sterile hypodermic needles for single use.
ISO 80369-7:Small-bore connectors for liquids and gases in healthcare applications — Part 7: Connectors for intravascular of hypodermic applications.
ISO 11607-1: Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems.
Environmentally requirements: ISO 14001.
Product description:
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).
Quincke bevel spinal needle.
Components & materials:
Cannula: stainless steel, without silicone coating.
Stylet: stainless steel, without silicone coating.
Base: polypropylene of polyamide.
Cap: rigid plastic.
-The Cannula is cylindrical; at one end it has a base that is either opaque of translucent, and at the other end a short bevelled tip, called a "Quinck".
This short spine bevelled tip, used around the spine, is designed to separate the dural fibres rather than cutting them, thus reducing damage and the loss of cerebrospinal fluid.
- The stylet is the same length as the tube; it fits properly into the needle lumen and indicates the bevel position of the needle.
- The base allows the needle to be connected to a syringe and is formed by a conical female Luer connection.
- hub (base) with standardized colour code corresponding to the external diameter of the needle.
-Transparent hub, to allow easy visualization of cerebrospinal fluid (CSF).
External diameter expressed in Gauge and mm.
Length expressed in mm.
Size selected: 22G (0.70 x 90mm) black, for spinal anaesthesia, adults.
Sterile and single use.
Initial sterilisation method: Ethylene oxide gas.
Shelf life to be included.
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. To prevent accidental needlestick injuries, never recap the needle after use.
Supplied with:
Manufacturer's instruction for use. Indications for use, warnings, storage conditions, disposal instructions etc.
Packaging and labelling: Shall be as per regulations applied to the device.
Primary packaging: Unit of use.
One (1) spinal needle in an individual sterilised peel pack.
Secondary packaging: Protected unit.
One (1) box of 50 spinal needles.
Symbols used according ISO 15223.
CE mark with Notified Body number.
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 (must comply to latest revisions of the standards):
ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.
ISO 7864:1993: Sterile hypodermic needles for single use.
ISO 80369-7:Small-bore connectors for liquids and gases in healthcare applications — Part 7: Connectors for intravascular of hypodermic applications.
ISO 11607-1: Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems.
Environmentally requirements: ISO 14001.
| Pack Size | Avg. Price |
|---|---|
| Pack of 1 | $0.41 |
| Pack of 25 | $10.13 |
| Pack of 50 | $19.43 |
| Pack of 100 | $49.27 |
