Identity
- Trade Name
- Biotronix Healthcare FDA UDI
- Generic Name
- Hypodermic needle, single-use FDA UDI
- Device Name
- Disposable 1cc LL, Syringe W/BioGuard Safety Needle 25G x 5/8", Each FDA UDI
- Model / Reference
- BIO-T-1048 FDA UDI
- Description
- Disposable 1cc LL, Syringe W/BioGuard Safety Needle 25G x 5/8", Each FDA UDI
Identifiers
- Catalog Number
- BIO-T-1048 FDA UDI
- Primary DI / UDI-DI
- 00850005165958 FDA UDI
- 510(k) Number
- K211555 FDA UDI
- FDA Product Code
- MEG FDA UDIFMF FDA UDIFMI FDA UDI
- GMDN Term
- Hypodermic needle, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5860 FDA UDI880.5570 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
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Hypodermic needle, single-useGeneral-purpose syringe, single-use
Biotronix Healthcare by Biotronix Healthcare Industries Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as General-purpose syringe, single-use.
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- BD Safety-Lok — BECTON DICKINSON AND COMPANY · Class II
- SURGYCO — Surgyco LLC · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Biotronix Healthcare Industries Inc.
Sources (1)
- FDA UDI 7665a678-5a68-4e36-88e2-78900703b41b 37 fields · synced May 30, 2026