Identity
- Trade Name
- droplet®, pen needles FDA UDI
- Generic Name
- Autoinjector needle FDA UDI
- Device Name
- Sterile single use droplet® pen needles, intended to be used with a pen injector device for the subcutaneous injection of drugs. FDA UDI
- Model / Reference
- 32G x 4 mm FDA UDI
- Description
- Sterile single use droplet® pen needles, intended to be used with a pen injector device for the subcutaneous injection of drugs. FDA UDI
Identifiers
- Catalog Number
- 7496 FDA UDI
- Primary DI / UDI-DI
- 05907996099382 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
No
FDA UDI
Category: Autoinjector needle
droplet®, pen needles by Htl Strefa S A — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Autoinjector needle.
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- 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
- Sure Comfort — ALLISON MEDICAL, INC. · 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
- Htl Strefa S A
Sources (1)
- FDA UDI e3bc2758-97af-4edf-b7fa-3b2158aaf9d1 35 fields · synced May 29, 2026