Identity
- Trade Name
- PolypVac® FDA UDI
- Generic Name
- ENT shaver system handpiece FDA UDI
- Model / Reference
- 3.3mm Microdebrider FDA UDI
Identifiers
- Catalog Number
- FG-000016 FDA UDI
- Primary DI / UDI-DI
- 00862519000304 FDA UDI
- FDA Product Code
- ERL FDA UDI
- GMDN Term
- ENT shaver system handpiece FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.4250 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
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: ENT shaver system handpiece
PolypVac® by Laurimed, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as ENT shaver system handpiece.
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- DIEGO — Gyrus Acmi, Inc. · Class II
- PolypVac® — Laurimed, 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
- Laurimed, LLC
Sources (1)
- FDA UDI e7fa8f5e-7404-4342-b90b-859ef89c98db 33 fields · synced May 31, 2026