Description
PIC SOLUTION
INSUPEN ORIGINAL
PEN NEEDLES
Description
Sterile pen needles to be combined with an adjustable injector for subcutaneous injections. Disposable, apyrogenic, non-toxic. In single self-protected packaging.
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/CE implemented with 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
Conservation
Valid for 5 years from the date of production in intact packaging.
Storage method and duration: store in a cool, dry place away from chemicals.
Format
Sterile pen needles to be combined with an adjustable injector for subcutaneous injections. Disposable, apyrogenic, non-toxic. In single self-protected packaging.
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/CE implemented with 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 method and duration: store in a cool, dry place away from chemicals.
Format
| CODE | NEEDLE MEASURE | DIAMETER | LENGTH | WALL |
| 0200001900001 | G29 | 0.33mm | 12mm | Regular Wall |
| 0200001000008 | G30 | 0.30 mm | 8mm | Regular Wall |
| 0200001100005 | G31 | 0.25mm | 5mm | Extra Thin Wall |
| 0200001100006 | G31 | 0.25mm | 6mm | Extra Thin Wall |
| 0200001100008 | G31 | 0.25mm | 8mm | Extra Thin Wall |
| 0200001200004 | G32 | 0.23mm | 4mm | Extra Thin Wall |
| 0200001200006 | G32 | 0.23mm | 6mm | Thin Wall |
| 0200226300008 | G33 | 0.20mm | 4mm | Extra Thin Wall |
| 0200226601008 | G34 | 0.18mm | 3.5mm | Extra Thin Wall |
