Needle,disp,23G,ster/BOX-100

General Description:
Needle with base (Luer type fitting and complies with ISO 594-1:1986, ISO 594-2:1998 and BS EN 20594-1:1994), and protective cap.

Blister packed.

Intended use: inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin

Technical specifications:
Material: Needle: Stainless steel conform to ISO 9626-1:1991.

Base and protective cap: medical grade plastic.

Measurements: External diameter expressed in Gauge and millimetres.

Length expressed in inch and millimetres.
Size selected: 23Gx1” (0.6x25mm).

Colour code: visible at the base of the needle and complies with ISO 6009-3:1992.

Disposable.

Sterile, (ethylene oxide sterilisation and compiles to BS EN 550:1994-ISO 11135-1:2007)

Standards:

Product and packaging conform to ISO 7864:1993, ISO 9626-1:1991, BS EN 550:1994, ISO 11135-1:2007.

Quality management system (QMS): Products and manufacturer must be certified and comply with ISO 13485: 2003 and 2008 requirements (or equivalent).

Marketing approval certificate: Product and manufacturer must conform to European Directive MDD 93/42/EEC on Medical Devices (or equivalent).

Packaging and labelling:
Primary packaging: Each needle packed in an individual sterilised peel-off pack made of paper and/or plastic.

Name of the manufacturer.
Manufacturer's product reference.
Type of product and main characteristics. If the packaging is not transparent, it must bear a diagram (preferably actual size) showing the essential parts of the product and indicating the position of the product in the packaging.
The word "sterile" (or equivalent harmonised symbol).
Sterilisation method (or equivalent harmonised symbol).
Lot number prefixed by the word "LOT"(or equivalent harmonised symbol).
Expiry date: month and year.
The words "for single use" (or equivalent harmonised symbol).
The words "check the integrity of the individual sterilisation protection before use" (if space allows).
The words "destroy after use" (if space allows).
CE marking.

Secondary packaging: Protective packaging - 1 carton of 100 needles.

Name and address of the manufacturer.
Manufacturer's product reference.
Type of product and main characteristics.
The word "sterile" (or equivalent harmonised symbol).
Sterilisation method (or equivalent harmonised symbol).
Lot number prefixed by the word "LOT"(or equivalent harmonised symbol).
Expiry date: month and year.
The words "for single use" (or equivalent harmonised symbol).
The words "check the integrity of the primary container individual sterile peel-pack before use" (if space allows).
The words "destroy after use" (if space allows).
Number of units per secondary package.
Information for particular storage conditions (temperature, pressure, light, humidity, etc.), as appropriate (or equivalent harmonised symbol).
Information for handling, if applicable (or equivalent harmonised symbol).
Manufacturer's instruction for use.
(Alternatively, the instruction for use can be indicated on a separate insert).
CE marking.

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