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Needle, luer, 23G, sterile - 1000647

Product ID: ITM-1000647
generic
IMPORTANT NOTE:
These technical specifications are generic and may vary depending on the selected Vendor.

Product description:
Needle with base (Luer type fitting), and protective cap.
Material: Needle: Stainless steel. Base and protective cap: plastic.
Sterile, single use (ethylene oxide sterilisation).
External diameter expressed in Gauge and millimeters.
Length expressed preferably in millimetres.
Size: 23G (0.6 x 25-27mm).
Cannula and tube:
Made of stainless steel.
Normal or thin-walled.
Long bevelled (angle inferior or equal to 13°), or short bevelled (angle between 13° and 19°).
Silicone-coated to facilitate insertion.
Base:
Allows the needle to be connected to a syringe or other injection devices.
Formed by a conical female Luer connection.
Designed in such a way that it prevents the needle from rolling on a flat surface.
Made of polypropylene (PP).
Internationally recognized colour code system allows easy identification of the hypodermic needle's external diameter.
Cap:
The cap protects the cannula and its bevel, and preserves the sterility of the needle.
Made of polypropylene (PP).

Instructions for use:
For subcutaneous (SC) injection: adults
For intravenous (IV) injection: children
For intramuscular (IM) injection: children
For intra-arterial: adults, children

Safety process:
The needle is for single use only.
When inserting a needle: use aseptic techniques.

Supplied with:
Manufacturer's instruction for use.

Packaging and labelling:
Primary packaging: Unit of use.
1 needle packed in an individual sterilised peel-pack made of paper and/or plastic.
Secondary packaging: Protected unit.
1 box of 100 blister packed needles.
Over packaging: Packaging unit.
X (protected units) packed in (extra packaging) rigid packaging with or without plastic film.
Symbols used according ISO 15223
CE mark with Notified Body number

Regulation & conformity requirements:
CE mark conforming to Medical Device Directive 93/42/EEC
CE Certificate ( class IIa)

Classification:
93/42/EEC Class IIa – CE certificate

Safety & product Standards:
Must comply with the following standards:
ISO 13485:2003 Medical devices -- Quality management systems -- Requirements for regulatory purposes
ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
ISO 11607-1:2007 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
ISO 6009:1992 Hypodermic needles for single use -- Colour coding for identification
EN 20594-1:1993 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements (ISO 594-1:1986)
ISO 7864:1993 Sterile hypodermic needles for single use.

Environmental requirements:
Use of other polymer instead of PVC

Pack SizeAvg. Price
Pack of 100$1.43