Identity
- Trade Name
- Plaxpot Multi Plasma FDA UDI
- Generic Name
- Electrosurgical handpiece, reusable FDA UDI
- Model / Reference
- GPX-2000 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809581025837 FDA UDI
- 510(k) Number
- K220493 FDA UDI
- FDA Product Code
- QVJ FDA UDI
- GMDN Term
- Electrosurgical handpiece, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Electrosurgical handpiece, reusable
Plaxpot Multi Plasma by Gcs Co. Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Gcs Co. Limited
Sources (1)
- FDA UDI c46cfd31-7db8-4d0b-8a79-c28b16ee3752 33 fields · synced Jun 8, 2026