Description
Sterile pen needles to be used with an adjustable injector for subcutaneous injections. Single-use, pyrogen-free, non-toxic. In self-protected individual packaging.
Latex-free.
General features
Triple-bevel needle, fully robotized.
Siliconized needle to facilitate skin penetration and reduce pain for the patient.
Anti-friction treatment of the cartridge tip to facilitate piercing the cap of the adjustable injector cartridge.
Sterilization with 10% Ethylene Oxide gas.
Compliant with EN ISO 11608-2.
Case with removable optical punch.
Indications for use
Therapy through subcutaneous injections.
Medical device according to Directive 93/42 CEE, amended by Directive 2007/47/CE, implemented by Legislative Decree n°37 of 25-01-2010
Class IIa
Conformity
EN ISO 11608-2 Pen needles
EN ISO 7864 Single-use 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	Directive 10/2011 CEE
Barrel	Non-toxic polypropylene	Directive 10/2011 CEE
Cannula	Stainless steel	ISO 9626
Silicone	Non-toxic and pyrogen-free for medical use	Eur. Ph. – U.S.P. current
Needle cover	Non-toxic polyethylene	Directive 10/2011 CEE
Adhesive	UV glue - non-toxic	Directive 10/2011 CEE

Storage
Validity 5 years from the production date in intact packaging.
Storage method and duration: store in a cool, dry place away from chemicals.

Format
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