Identity
- Trade Name
- McKesson FDA UDI
- Generic Name
- Insulin syringe/needle, safety FDA UDI
- Device Name
- Syringes with Safety Needles 1CC | TUBERCULIN 28G x 1/2 in (100/bx, 8/cs) FDA UDI
- Model / Reference
- 16-SFTYSFN3 FDA UDI
- Description
- Syringes with Safety Needles 1CC | TUBERCULIN 28G x 1/2 in (100/bx, 8/cs) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 20612479228478 FDA UDI
- FDA Product Code
- MEG FDA UDI
- GMDN Term
- Insulin 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
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: Insulin syringe/needle, safety
McKesson by Mckesson Medical-Surgical Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Insulin syringe/needle, safety.
- SecureSafe Syringe With Safety Needle — Dynarex Corp. · Class II
- RELI — MYCO MEDICAL SUPPLIES INC. · Class II
- ONE-CARE Safety Pen Needles 30G x 8mm, Yellow, — MediVena, LLC · Class II
- Endure — ENDURE INDUSTRIES, INC. · Class II
- Disposable Insulin Syringe — Berpu Medical Technology Co., Ltd · Class II
- RELI — MYCO MEDICAL SUPPLIES INC. · Class II
- Disposable Insulin Syringe — Berpu Medical Technology Co., Ltd · Class II
- SecureSafe Safety Insulin Syringe — Dynarex Corp. · Class II
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
- Mckesson Medical-Surgical Inc.
Sources (1)
- FDA UDI 499caed5-39e2-4741-a17d-9bb662973f36 33 fields · synced Jun 6, 2026