NEEDLETECH

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Needletech, hypodermic needles (Medical Device CE0476 of our production)
Size:
30G – 13mm
31G – 13mm
31G – 6mm
31G – 4mm


Main Field of Coverage:
 Mesotherapy
 Botulinum Toxin
 Sclerotherapy
 Diabetes
(Size 31G da 6mm is also indicated for insulin pens).

GMDN:
An extremely fine, sharply-pointed metal tube that is used in conjuction with syringes for puncture into certain sites on the patient’s body, e.g., the eyeball, for the introduction/extraction of very small quantities of a medium, e.g., a body fluid, gas, or a medication.
Also known as a microlance, it will tipically have a standard Luer-lock connector at the proximal end.
This is a single-use device.

93/42/EEC DIRECTIVE - Annex II, without point 4, transposed in Italy by Dlgs. 46 of 1997/02/24.
CE Classification: Class IIa

Technical Datas
Description: Hypodermic needle for the administration of Injections and blood and body fluids to patient’s consumption.
Destination of use in accordance with D.lgs. 46/97: Professional
Presence of Substances/Tissues: NO
Presence of Drugs: NO
The main materials which constitute the primary packaging of this MD, don’t require special conditions of disposal: NO
Sterile: YES

List of Sterilization Methods
Sterilization Method: ETHILENE OXIDE
Maximum period of use (months): 24
Sterilization Method validated in accordance to harmonized standards: NO

Single-use: YES
Latex – during manufactuing process the product came into contact with Latex molecules: NO
Latex – both the product and its packaging are free of latex: YES
Materials which constitute the MD at direct contact with the Patient
Material: STAINLESS STEEL
Special condition of disposal: YES
List of Packaging’s materials:
PAPER/PLASTIC LAMINATE COMBINATION

Download Conformity CE