SYRINGE INJ.LIGHT 5CC WITH NEEDLE 21G RAYS

Syringe 5cc with detachable needle 21g InJ/Light Rays

Syringe 5cc with detachable needle 21g InJ/Light. Non-toxi and non pyrogenic, transparent polypropylene, needle of AISI 304 stainless stell with triple bevelling, sterile, disposable, individual blister pack. RAYS Italy.

Non-toxic and non-pyrogenic Syringe composed by: Transparent medical polypropylene Cylinder provided with a black graded scale.
-The syringes may have the cone as followes:

•  Luer cone
• Polypropylene medical plunger
• The plunger fitted with a final latex free piston ring.
• with detachable needle 21g

Product name: INJ-LIGHT 5521CM38

Use: Disposable Syringe with several sizes,  eccentric luer cone, ntended to be used or parenteral infusions and washings (Short-term, surgical and invasive device)

Sterilization method: Ethylene oxide Sterilization (EtO)
Gas remainders: as currently in force rules
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.
DHEP 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 ensures 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.

Usage and instructions: Sterile, non-toxic and non-pyrogenic, in polypropylene. For injection or washes. Used by health care workers. For single use. In case of reuse infection is possible. Consult a doctor. Before use, check expiry date and open the packaging and use. Check the integrity of the packaging before the use. Don’t use if the packaging is damaged. Do not dispose in the environment.
Barcode: On each single packaging of blister, it is printed the EAN 13 barcode
Disposal: Disposal has to be conducted according to national regulations.
The incineration or the disposal of the product must be done under the controlled conditions. If the product doesn’t come into contact with infective agents or other risky materials it does not produce toxic remainders.
Storage: Keep in dry and fresh place, away from the direct sunlight or heat sources, at between the temperatures 5 and 50°C.

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 UNI EN ISO 20594 (1994)Conical connectors with conicity 6% (Luer), for syringes, needles and other medical instrumentation, general requirements 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 is classified to the purpose of EC marking that product belongs to IIa class.
Certificate EC: EC Certificate n. MED 29041 issued by Notified Body n. 0476 - Cermet Scarl and is released to Rays S.p.A. on 01/05/2010 and valid till 30/04/2015 in conformity with the requirements of Directive EEC 93/42 as per attached V.
Manufacturer: Rays SPA