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