Description
Sterile pen needles to be combined with an adjustable injector for subcutaneous injections. Disposable, apirogenic, non-toxic. In single self-protected package.
No latex.
General characteristics
Ago to three-fold totally robotic grinding.
Needle jamming to facilitate penetration in the skin and reduce the feeling of pain for the patient.
Anti-friction treatment of the cartridge tip to facilitate the drilling of the adjustable injector cartridge.
Ethylene Oxide gas sterilization at 10%.
Conform to EN ISO 11608-2.
Removable optic hanger.
Indications of use
Therapy by subcutaneous injections.
Medical device according to Directive 93/42 EEC as amended by Directive 2007/47/EC D.Lgs. n°37 of 25-01-2010
Class II
Compliance
EN ISO 11608-2 Pen needles
EN ISO 7864 Disposable Hypodermal Needles
EN ISO 9626 Stainless steel
ISO 2859 sampling plants
EN ISO 11135 Sterilization
EN ISO 10993-1 Biocompatibility System Quality assurance: certified according to ISO 9001
Quality assurance system: certified according to ISO 13485

COMPONENT	MATERIALS	CONFORMATION
Primary container	Non-toxic polyethylene	Directive 10/2011 EEC
Bariletto	Non-toxic polypropylene	Directive 10/2011 EEC
Cannula	Stainless steel	ISO 9626
Silicone	Atoxic and apirogen for medical use	Eur. Ph. – U.S.P. in force
Covers and needle	Non-toxic polyethylene	Directive 10/2011 EEC
Collar	UV glue - atoxic	Directive 10/2011 EEC

Conservation
Validity 5 years from the date of production in full packaging.
Mode and shelf life: keep in a cool and dry place away from chemicals.

Format

CODE	MISURA AGO	DIAMETER	Length	PARE
0200001900001	G	0.33 mm	12 mm	Regular Wall
0200001000008	G30	0,30 mm	8 mm	Regular Wall
0200001100005	GREAT	0.25 mm	5 mm	Extra Thin Wall
0200001100006	GREAT	0.25 mm	6 mm	Extra Thin Wall
0200001100008	GREAT	0.25 mm	8 mm	Extra Thin Wall
0200001200004	GREAT	0.23 mm	4 mm	Extra Thin Wall
0200001200006	GREAT	0.23 mm	6 mm	Thin Wall
0200226300008	GREEN	0.20 mm	4 mm	Extra Thin Wall
0200226601008	G	0.18 mm	3.5 mm	Extra Thin Wall