Description
Sterile pen needles to be combined with an adjustable injector for subcutaneous injections. Single-use, apyrogenic, nontoxic. In single, self-protected package.
Latex-free.
General features
Fully robotic triple sharpening needle.
Silicon-coating of the needle to facilitate penetration into the skin and reduce pain sensation for the patient.
Anti-friction cartridge tip treatment to facilitate drilling of the adjustable injector cartridge cap.
Ethylene Oxide gas sterilization at 10%.
Compliant with EN ISO 11608-2.
Case equipped with removable optical die-cut.
Indications for use
Therapy by subcutaneous injections.
Medical device according to Directive 93/42 EEC as amended by Directive 2007/47/EC implemented by Legislative Decree No. 37 of 25-01-2010
Class IIa
Compliance
EN ISO 11608-2 Pen needles
EN ISO 7864 Disposable hypodermic needles
EN ISO 9626 Stainless steel
ISO 2859 Sampling plans
EN ISO 11135 Sterilization
EN ISO 10993-1 Biocompatibility Quality Assurance System: certified according to ISO 9001
Quality Assurance System: certified according to ISO 13485

COMPONENT	MATERIAL	CONFORMITY
Primary container	Non-toxic polyethylene	EEC Directive 10/2011
Barrel	Non-toxic polypropylene	EEC Directive 10/2011
Cannula	Stainless steel	ISO 9626
Silicone	Non-toxic and apyrogenic for medical use	Eur. Ph. - U.S.P. current
Needle cover	Non-toxic polyethylene	EEC Directive 10/2011
Adhesive	UV glue - non-toxic	EEC Directive 10/2011

Conservation
Validity 5 years from date of production in unopened package.
Storage method and shelf life: store in a cool, dry place away from chemicals.

Format

CODE	NEEDLE MEASURE	DIAMETER	LENGTH	WALL
0200001900001	G29	0.33 mm	12 mm	Regular Wall
0200001000008	G30	0.30 mm	8 mm	Regular Wall
0200001100005	G31	0.25 mm	5 mm	Extra Thin Wall
0200001100006	G31	0.25 mm	6 mm	Extra Thin Wall
0200001100008	G31	0.25 mm	8 mm	Extra Thin Wall
0200001200004	G32	0.23 mm	4 mm	Extra Thin Wall
0200001200006	G32	0.23 mm	6 mm	Thin Wall
0200226300008	G33	0.20 mm	4 mm	Extra Thin Wall
0200226601008	G34	0.18 mm	3.5 mm	Extra Thin Wall