Identity
- Trade Name
- US DIAGNOSTICS FDA UDI
- Generic Name
- Insulin syringe/needle, basic FDA UDI
- Device Name
- U-100 insulin syringe 0.3cc 31g 5/16" 8mm FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- U-100 insulin syringe 0.3cc 31g 5/16" 8mm FDA UDI
Identifiers
- Catalog Number
- 8-57513-00652-0 FDA UDI
- Primary DI / UDI-DI
- 00857513006520 FDA UDI
- FDA Product Code
- FMF FDA UDI
- GMDN Term
- Insulin syringe/needle, basic 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Insulin syringe/needle, basic
Us Diagnostics by Carelife (usa) Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Carelife (usa) Inc.
Sources (1)
- FDA UDI 8e1d7f00-6b29-4922-b26f-23917aa3cd24 35 fields · synced Jun 6, 2026