Needle,disp,21G,ster/BOX-100

General Description:
Needle, disposable, 21Gx1 1/2” (0.8x40mm), sterile, box of 100

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

Technical specifications:
Components: Needle with base (Luer type fitting and complies with ISO 80369-7:2021), and protective cap.
Material: Needle: Stainless steel conform to ISO 9626:2016.
Base and protective cap: medical grade plastic.
Measurements: External diameter expressed in Gauge and millimetres.
Length expressed in inch and millimetres.
Size selected: 21Gx1 1/2” (0.8x40mm).
Colour code: visible at the base of the needle and complies with ISO 6009:2016.

Disposable.

Sterile, (ethylene oxide sterilization and compiles to ISO 11135:201)

Standards:
Product and packaging conform to ISO 7864:2016, ISO 9626:2016, ISO 11135:2019.
Quality management system (QMS): Products and manufacturer must be certified and comply with ISO 13485: 2016 requirements (or equivalent).
Marketing approval certificate: Product and manufacturer must conform to European Medical Device Regulation (EU) 2017/745 (or equivalent).

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

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