Identity
- Trade Name
- Ultra-Care Pen Needles 32G 1/4" 100 Ct FDA UDI
- Generic Name
- Autoinjector needle FDA UDI
- Device Name
- Insulin Pen Needle FDA UDI
- Model / Reference
- 240396 FDA UDI
- Description
- Insulin Pen Needle FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00372217006046 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
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
Category: Autoinjector needle
Ultra-Care Pen Needles 32G 1/4" 100 Ct by Arise Medical Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Autoinjector needle.
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- 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 |
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Manufacturer
- Manufacturer
- Arise Medical Llc
Sources (1)
- FDA UDI 40a9d407-90be-44b6-8175-dfd6c2a994b9 33 fields · synced May 30, 2026