Identity
- Trade Name
- AboutTime 32G x 4mm Pen Neddles FDA UDI
- Generic Name
- Autoinjector needle FDA UDI
- Device Name
- AboutTime 32G x 4mm Pen Neddles, Universal fit FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- AboutTime 32G x 4mm Pen Neddles, Universal fit FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00628465045215 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
Yes
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Autoinjector needle
AboutTime 32G x 4mm Pen Neddles by Medical Plastic Devices M.P.D. Inc — 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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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
- Medical Plastic Devices M.P.D. Inc
Sources (1)
- FDA UDI 9b5720b4-3842-4482-99f1-3f492c1da2e8 33 fields · synced May 30, 2026