Identity
- Trade Name
- Nano 2nd Gen FDA UDI
- Generic Name
- Autoinjector needle FDA UDI
- Device Name
- Nano™ 2nd Gen Pen Needles, 4mm, 32G, 5bevel, UTW FDA UDI
- Model / Reference
- 320550 FDA UDI
- Description
- Nano™ 2nd Gen Pen Needles, 4mm, 32G, 5bevel, UTW FDA UDI
Identifiers
- Catalog Number
- 320550 FDA UDI
- Primary DI / UDI-DI
- 00383017055035 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
- Needle Gauge — 32 Gauge FDA UDILength — 4 Millimeter FDA UDI
Category: Autoinjector needle
Nano 2nd Gen by embecta Medical II LLC — 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
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- EasyDrip Pen Needles 30G 8mm — Sandstone Medical (Suzhou) Inc. · Class II
- droplet®, pen needles — HTL STREFA S A · 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
- embecta Medical II LLC
Sources (1)
- FDA UDI 047f66e6-1512-4f7e-8a02-f859746a0806 35 fields · synced Jun 9, 2026