Identity
- Trade Name
- Ultra-Fine FDA UDI
- Generic Name
- Insulin syringe/needle, basic FDA UDI
- Device Name
- Ultra-Fine™ Insulin Syringes, U-100, 12.7mm, 30G, 1mL FDA UDI
- Model / Reference
- 328278 FDA UDI
- Description
- Ultra-Fine™ Insulin Syringes, U-100, 12.7mm, 30G, 1mL FDA UDI
Identifiers
- Catalog Number
- 328278 FDA UDI
- Primary DI / UDI-DI
- 10383017827813 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
Yes
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
Dimensions & Sizes
- Size
- Needle Gauge — 30 Gauge FDA UDILength — 12.7 Millimeter FDA UDI
Category: Insulin syringe/needle, basic
Ultra-Fine by embecta Medical II LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Insulin syringe/needle, basic.
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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
- embecta Medical II LLC
Sources (1)
- FDA UDI 8a849915-794b-4ae5-a9bf-b86e5cae48b1 35 fields · synced Jun 9, 2026