Farmalabor Pack

STERILE PACK

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STERILE DISPOSABLE SYRINGE FOR TUBERCULI

STERILE DISPOSABLE SYRINGE FOR TUBERCULI

CODIFA: 970147599
TIPOLOGY: STERILE PACK
CODE: 014870
QUANTITY: CONF. 10 PZ

FEATURES

Triple contact rubber piston.
High transparency polypropylene.
Highly legible and stable graduated scale.
High penetrability needle.
End stroke piston stop device.
In single blister

Medical device according to directive 93/42 EEC
Implementation with Legislative Decree No. 46 of 02-24-97
Class II A

Compliance:
ISO 594-1 Conical Luer connections 6%
ISO 7864 Disposable hypodermic needles
ISO 7886 Sterile disposable syringes
ISO 2859 Sampling plans
ISO 6009 Color coding of identification
ISO 683/12 Stainless steel
EN 550 Sterilization
ISO 10993 Biocompatibility
Quality Assurance System: certified according to UNI EN ISO 9001: 2000
Quality Assurance System: certified according to UNI EN ISO 13485: 2004

Stairs division:
Nominal volume: 1 ml
Graduation up to: 1 ml
Min division: 0.01 ml
Standard: ISO 8537

Technical specifications:
COMPONENT: Cylinder, MATERIAL: Non-toxic polypropylene for medical use, COMPLIANCE: EEC Directive 72/2002;
COMPONENT: Piston, MATERIAL: Non-toxic polypropylene for medical use, COMPLIANCE: EEC Directive 72/2002;
COMPONENT: Rubber, MATERIAL: Latex-free compound, COMPLIANCE: FU / FE in force;
COMPONENT: Silicone, MATERIAL: Non-toxic and non-pyrogenic for medical use Max Qty 0.25 mg / cm2, COMPLIANCE: FE / U.S.P. in force;
COMPONENT: Conect, MATERIAL: Non-toxic polypropylene for medical use, COMPLIANCE: EEC Directive 72/2002;
COMPONENT: Cannula, MATERIAL: AISI 304 stainless steel, CONFORMITY: ISO 683/13;
COMPONENT: Needle cover, MATERIAL: Non-toxic polypropylene for medical use, COMPLIANCE: EEC Directive 72/2002;
COMPONENT: Glue, MATERIAL: Epoxy-non-toxic glue, COMPLIANCE: EEC Directive 91/155;
COMPONENT: Screen printing ink, MATERIAL: Non-toxic specific for polypropylene, CONFORMITY: Ministerial Decree 21-03-73 and subsequent amendments.

Presence of latex: NO

Product sterilization method:
Ethylene Oxide Gas in accordance with EN 550

Packaging material:
Component: Single blister, Material: Medical paper, Compliance: F.D.A (section 21-CFR176-170);
Component: Single blister, Material: Thermoformed tray in PVC coupled with PE + PP + PA, Compliance: Ministerial Decree 21-03-73 and subsequent amendments.
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