Identity
- Trade Name
- NovoFine® 30G FDA UDI
- Generic Name
- Autoinjector needle FDA UDI
- Device Name
- NovoFine® 30G is a sterile, nontoxic, non-pyrogenic, single use injection needle designed and recommended for use with FlexPen® and all other Novo Nordisk® insulin delivery devices. FDA UDI
- Model / Reference
- 185250 FDA UDI
- Description
- NovoFine® 30G is a sterile, nontoxic, non-pyrogenic, single use injection needle designed and recommended for use with FlexPen® and all other Novo Nordisk® insulin delivery devices. FDA UDI
Identifiers
- Catalog Number
- 185250 FDA UDI
- Primary DI / UDI-DI
- 00301691852504 FDA UDI
- FDA Product Code
- GAA FDA UDI
- GMDN Term
- Autoinjector needle FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Commercial Distribution
- Not 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 8 Millimeter FDA UDINeedle Gauge — 30 Gauge FDA UDI
NovoFine® 30G by Novo Nordisk Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 I | Pending data |
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Manufacturer
- Manufacturer
- Novo Nordisk Inc.
Sources (1)
- FDA UDI 4132104a-d8a8-4510-9c7b-a792b6310c32 37 fields · synced May 31, 2026