PIC SOLUTION

INSUPEN ORIGINAL

PEN NEEDLES

Description
Sterile pen needles for use with an adjustable injector for subcutaneous injections. Disposable, pyrogen-free, and non-toxic. Individually packaged and protected.
Latex free.
General characteristics
Fully robotic triple-sharpened needle.
Silicone coating of the needle to facilitate penetration into the skin and reduce the sensation of pain for the patient.
Anti-friction treatment of the cartridge tip to facilitate drilling of the adjustable injector cartridge cap.
Sterilization with 10% ethylene oxide gas.
Compliant with EN ISO 11608-2.
Pencil case with removable optical die.
Directions for use
Therapy by subcutaneous injections.
Medical device according to Directive 93/42 EEC 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 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	COMPLIANCE
Primary container	Non-toxic polyethylene	Directive 10/2011 EEC
Barrel	Non-toxic polypropylene	Directive 10/2011 EEC
Cannula	Stainless steel	ISO 9626
Silicone	Non-toxic and non-pyrogenic for medical use	Eur. Ph. – Current USP
Needle cover	Non-toxic polyethylene	Directive 10/2011 EEC
Glue	UV glue - non-toxic	Directive 10/2011 EEC

Conservation
Valid for 5 years from the date of production in intact packaging.
Storage conditions and duration: Store in a cool, dry place away from chemicals.

Format

CODE	NEEDLE MEASUREMENT	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