SYRINGE INSU/LIGHT 1CC WITH NEEDLE 27G RAYS

Syringe 1cc with detachable needle 27g InSu/Light Rays

Syringe 1cc with detachable needle 27g InSu/Light. Non-toxic and non pyrogenic, transparent polypropylene, needle of AISI 304 stainless stell with triple bevelling, sterile, disposable, individual blister pack. RAYS Italy.

Non-toxic, non-pyrogenic syringe in an appropriate plastic material for medical use composed by:
- Polypropylene medical transparent cylinder provided with a black graduated scale, with lock ring which prevents the escape of the piston
- Scale in U.I. with indication of capacity in ml
- Cylinder in polypropylene
- Latex free piston lubricated with silicone oil for a smooth and controlled leak
- Fixed non-traumatic needle stainless steel with triple sharpening
- Double cap, needle orange cap and transparent piston cap, warranty of sterility

Commercial Name: INSU-LIGHT

Intended Use: Disposable Insulin Syringe with fixed needle, no-dead space,sterile, three parts and destined to parenteral use (short-term, surgical and invasive device)

Range of product: Insulin syringes are available in the following measures:
PRODUCT CODE   CAPACITY NEEDLE        QUANTITY BOX/CARTON

SU1-29G13          1 ml 29G – 0,33x12,7 mm       100/800
SU1-30G08          1 ml 30G – 0,3x8 mm             100/800
SU5-29G13        0,5 ml 29G – 0,33x12,7 mm      100/800
SU5-30G08        0,5 ml 30G – 0,3x8 mm            100/800
SU3-30G08        0,3 ml 30G – 0,3x8 mm            100/800
SU3-29G13        0,3 ml 29G – 0,33x12,7 mm      100/800

Needle: Stainless steel with triple sharpening lubricated with silicone oil in quantities less than 0,25 mg, with cap in PP. The needle is designed according to the thin-wall technology
Sterilization Method: Ethylene oxide Sterilization (EtO) Residual quantity of gas according to current regulations
Sterilization validity: 5 years from the manufacture date.
Latex free: The syringe is completely latex free, thus eliminating the risk of allergic reactions to latex.
PVC free: The syringe is completely PVC free, thus eliminating the risk of contamination by phthalates.
Packaging: Single blister packaging that consists of medical paper and PP film ensuring the maximum safety concerning the sterilization and the impermeability.That prevents the formation of paper scraps during the opening operation. On the packaging the sterilization date, expiry date and the lot number are clearly typed and also printed on the outside part of the dispenser where the quantity and the type of the syringe are clearly indicated.
Barcode: On each single packaging of blister, it is printed the EAN 13 barcode.
Usage and instructions: Sterile, non-toxic and non-pyrogenic, in polypropylene. For injection. Used by health care workers. For single use. In case of reuse infection is possible. Consult a doctor. Before use, check the integrity of the packaging and expiry date, open the packaging and use. Don’t use if the packaging is damaged. Do not dispose in the environment.
Disposal: Disposal has to be conducted according to national regulations.
The incineration or the disposal of the product must be done under controlled conditions. If the product doesn’t come in contact with infective agents or other risky materials, it does not produce toxic remainders.
Storage: Keep in dry and fresh place, away from direct sunlight or heat sources, at temperatures between 5 and 50°C.
Compatibility with pharmaceutical products: The product doesn’t interact with the substances it’s used with, and episodes of incompatibility with drugs, disinfectants, infusion solutions, biological materials, which are not explicitly considered incompatible with the constituent materials of the product, are not known. For incompatible drugs with polypropylene and photosensitive solutions, specific products are available.
Production place: Manufacturing Facilities in ISO 9001:2008 e ISO 13485:2004 certificated factories.
Conformity: Conform to standard ISO 7886-1998 disposal and sterile Hypodermic syringes- Syringes for manual use.
Conform to standard UNI EN 10993 for biological valuation of medical devices.
Conform to standard ISO 8537-2008 for the chemical and biologic properties of the insulin syringe
Conform to standard ISO 7864:1998 sterile and disposal hypodermic needles
Conform to standard UNI EN ISO 683 aluminium and aluminium alloys
Conform to standard UNI EN 9626-2002 steinless steel tube for needle
conform to the directive 93/42/CEE related to Medical devices modified by 2007/47/EEC
Classification: The Legislative Decree 46/97 on Medical Device classifies to the purpose of EC marking this product to IIa class.
Certificate EC: EC Certificate n. IT268973

Manufacturer: Rays SPA