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E013-044

SF - Immunization Devices
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Product Details
Product name
Safegard Retractable safety syringe 1ml Tuberculin
IMD-PQS Code
E013-044
Status
Prequalified
Date of acceptance
22 Feb 2010
Appliance type
E013
Product description
RUP retractable 1ml Tuberculin
Manufacturer
Safegard Medical (Hungary) Kft
Manufacturer Reference
Safegard Retractable safety syringe 1ml Tuberculin
Country of Manufacture
Hungary
Address
Jószerencsét tér 15 3608 Farkaslyuk
Hungary
Telephone
+36 48 470758
Website address
Valid until
31 May 2026
Specifications

Product specifications - Main

Intended purpose
Medication variable dose administration
Restrictive use for
Tuberculin administration
Graduations (ml)
0.01
Needle Size
Other
Needle Size (Other)
27G x 1/2"
Needle Fixation
Fixed
Nominal capacity (ml)
1.00
Packaging & Sterility Assurance
Yes
Other needle size options
Yes
Plunger aspiration
Yes
Number of pieces
3.00
RUP mechanism
Needle retraction
RUP Type
Other
Location RUP activation
End of injection
RUP Needle Fixation
Fixed
RUP Needle Sizes
27G x 3/8" (10 mm)
RUP Nominal Capacity (ml)
1.00
RUP plunger Aspiration
Multiple
RUP Primary Packaging
Blister pack
RUP Sub-category
Retractable RUP
CE marking
Yes
Comments
The retraction of the needle is considered as a reuse prevention feature (RUP) and a Sharp Injury Protection (SIP)

Price and shipping

Shipping volume (m3)
0.056
Shipping weight (kg)
5.40
Pieces per package
100
Minimum order
1000.00
Price 1
0.08 US$/pc
Year of base price
2016
Incoterms
FCA

Quality standard

Quality Standard
ISO 13485
Specification Reference
Applicable PQS specification: ISO 7886-4
Applicable PQS VP(s): ISO 7886-4
Product Sites
Safegard Medical (Hungary) Kft
Jószerencsét tér 15 3608 Farkaslyuk
Hungary
Document Details