DEVICE: HEPRO.US - Tuberculin Syringes - 1ml/cc 25G x 5/8" (00850578007426)

Device Identifier (DI) Information

HEPRO.US - Tuberculin Syringes - 1ml/cc 25G x 5/8"
CT - Tuberculin 1ml/cc 25G x 5/8"
In Commercial Distribution

HEPRO.US INC.
00850578007426
GS1

3000
080061451 *Terms of Use
30 Boxes per Case - 10 Bags of HEPRO.US - Tuberculin Syringe attached needle, 1ml/cc 25G x 5/8"
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Device Characteristics

MR Safe
No
No
Yes
No
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
32592 Tuberculin/allergy syringe/needle, safety
A sterile device consisting of a calibrated barrel (cylinder) with plunger, with an attached needle (sometimes shielded), intended to be used to administer a precise, low-dosage injection of tuberculin and/or sensitivity test allergen to a patient subcutaneously. The syringe is typically made of plastic and silicone materials and will have plunger anti-sticking properties allowing smooth plunger movement. It can be used by healthcare personnel or patients. After use, the needle can be fully retracted into the barrel, providing protection against needle sticks and rendering the device unusable. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
FMF Syringe, Piston
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

b489327d-4599-4bff-abdb-f9e316c93614
March 29, 2018
2
June 21, 2017
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: 85057800742602 CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
Yes
Yes
Yes
Yes CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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