Descrizione Clinica
Diabetes and Glycemia - Pic insupen adv needle g33x4mm Pic
PIC SOLUTION
INSUPEN ORIGINAL
PENNA AGHI
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
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
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 |
