Identity
- Trade Name
- Unifine Ultra FDA UDI
- Generic Name
- Autoinjector needle FDA UDI
- Device Name
- Unifine Ultra Pen Needles - 8mm x 31G FDA UDI
- Model / Reference
- AN 4130 FDA UDI
- Description
- Unifine Ultra Pen Needles - 8mm x 31G FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00384704130011 FDA UDI
- FDA Product Code
- FMI FDA UDI
- GMDN Term
- Autoinjector needle FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5570 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
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
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 8 Millimeter FDA UDINeedle Gauge — 31 Gauge FDA UDI
Category: Autoinjector needle
Unifine Ultra by Owen Mumford Usa Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Autoinjector needle.
- MICRON, droplet pen needle — HTL STREFA S A · Class II
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- droplet®, pen needles — HTL STREFA S A · Class II
- Nano 2nd Gen — embecta Medical II LLC · Class II
- BD Ultra-Fine — BECTON DICKINSON PEN LIMITED · Class II
- Insulin Pen Needle — Berpu Medical Technology Co., Ltd · Class II
- ONE-CARE Pen Needles — MediVena, LLC · 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
- Owen Mumford Usa Incorporated
Sources (1)
- FDA UDI a075ea4f-a457-4b2f-9694-e07ba34116f5 36 fields · synced May 30, 2026