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HEPRO.US - Tuberculin Syringe attached needle, 1ml/cc 25G x 5/8"

FDA UDI

Class II (US FDA UDI)

by Hepro.us Inc.

Identity

Trade Name
HEPRO.US - Tuberculin Syringe attached needle, 1ml/cc 25G x 5/8" FDA UDI
Generic Name
Tuberculin/allergy syringe/needle, safety FDA UDI
Device Name
Tuberculin Syringe permanently attached needle, 1ml/cc 25G x 5/8", 10 pcs per Bag, 10 Bags per Box FDA UDI
Model / Reference
BX Tuberculin Syringe 1ml/cc 25G x 5/8" FDA UDI
Description
Tuberculin Syringe permanently attached needle, 1ml/cc 25G x 5/8", 10 pcs per Bag, 10 Bags per Box FDA UDI

Identifiers

Primary DI / UDI-DI
00850578007365 FDA UDI
FDA Product Code
FMF FDA UDI
GMDN Term
Tuberculin/allergy syringe/needle, safety FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.5860 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Safe FDA UDI

Category: Tuberculin/allergy syringe/needle, safety

HEPRO.US - Tuberculin Syringe attached needle, 1ml/cc 25G x 5/8" by Hepro.us Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Tuberculin/allergy syringe/needle, safety.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Hepro.us Inc.

Sources (1)

  • FDA UDI fb453b1c-b08c-49cf-bd8a-be926113cd8f 33 fields · synced Jun 1, 2026