NEEDLE, s.u., Luer, retractable, 23Gx32 mm, blue (SafeR)
STD
SINSNEEDR23
Valid Article
HS Code:
901839
Last Updated on:
07/11/2024, 18:13:04
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).
A0101010101 - Hypodermic syringe needles, with safety systems
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.
In Europe, medical material that fulfills the definition of a medical device according to the MDR (Medical Device Regulation) is classified into 4 classes
Thermosensitive codes are defined for storage and transportation temperature requirements of the products.
NEEDLE, retractable, (SafeR)
Definition
A sterile, sharp bevel-edged, hollow tubular metal device intended to be used in conjunction with syringes to administer fluids or medications to a patient.
SafeR® Sting is a retractable safety stainless steel needle, designed for use with SafeR® Syringes only.
Specifications
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Quality standards
- ISO 7864, 2016, edition 4, (confirmed 2021) Sterile hypodermic needles for single use - Requirements and test methods
- ISO 9626, 2016, edition 2, (confirmed 2021) Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods
- ISO 6009, 2016, edition 4, (confirmed 2021) Hypodermic needles for single use - Colour coding for identification
- ISO 80369-7, 2021, edition 2, Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications
- ISO 23908, 2013, edition 1, Sharps injury protection - Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling
Technical specifications
- NEEDLE
- stainless steel
- tapered bevel
- lubricated
- with protective sheath
- HUB
- polypropylene, etc.
- female Luer connector
- standardized colour code (ISO 6009)
- Sterile, for single use
availble sizes:
Nominal size | external Ø | length | colour |
21 G | 0.8 mm | 38 mm | green |
23 G | 0.6 mm | 32 mm | blue |
25G | 0.5 mm | 25 mm | orange |
Packaging & Labelling
Unit sterile packaging in peel-open pack
To be Ordered Separately
SafeR® Syringes
Instructions for use
- Plan safe handling and disposal before any procedure
- Use safe and effective needle alternatives when available
- Immediately dispose of contaminated needles in a sharps container
Precautions for Use
To prevent accidental needlestick injuries, never recap the needle after use.
Storage
Shelf life 3 years.
No special storage or transportation condition. Recommendations to store in room temperature. Store in dry and warm place and not exposed to strong light.
MSF requirements
Allows injections using devices with a sharp injury prevention (SIP), important in VHF context.
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