Identity
- Trade Name
- Pen Needle FDA UDI
- Generic Name
- Autoinjector needle FDA UDI
- Device Name
- ReliOn Pen Needles 8mm x 31 Gauge (5/16" x 0.25mm) Pen Needles 50 count FDA UDI
- Model / Reference
- 320616 FDA UDI
- Description
- ReliOn Pen Needles 8mm x 31 Gauge (5/16" x 0.25mm) Pen Needles 50 count FDA UDI
Identifiers
- Catalog Number
- 320616 FDA UDI
- Primary DI / UDI-DI
- 00681131386814 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
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
- Length — 8 Millimeter FDA UDINeedle Gauge — 31 Gauge FDA UDI
Category: Autoinjector needle
Pen Needle by Walmart Stores — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Autoinjector needle.
- Unifine Ultra — OWEN MUMFORD USA INCORPORATED · Class II
- MICRON, droplet pen needle — HTL STREFA S A · Class II
- SureFine Pen Needle 31Gx8mm — SHINA MED CORPORATION · Class II
- EasyDrip Pen Needles 30G 8mm — Sandstone Medical (Suzhou) Inc. · Class II
- 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
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
- Walmart Stores
Sources (1)
- FDA UDI d8c9259f-672b-4041-bab5-8b90c5967f31 35 fields · synced May 29, 2026