Identity
- Trade Name
- Pen Needles, 31G x 8MM FDA UDI
- Generic Name
- Autoinjector needle FDA UDI
- Device Name
- PEN NDL 31G 8MM 100 BX 1200 PL FDA UDI
- Model / Reference
- 320981 FDA UDI
- Description
- PEN NDL 31G 8MM 100 BX 1200 PL FDA UDI
Identifiers
- Catalog Number
- 320981 FDA UDI
- Primary DI / UDI-DI
- 00382903209811 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
- 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
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 8 Millimeter FDA UDINeedle Gauge — 31 Gauge FDA UDI
Pen Needles, 31G x 8MM by Becton Dickinson Pen Limited — Class II — 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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Becton Dickinson Pen Limited
Sources (1)
- FDA UDI 56b2b66f-72ea-45ef-8fd1-f355a2ef7a95 36 fields · synced Jun 8, 2026