Identity
- Trade Name
- FINESSE FDA UDI
- Generic Name
- Electrosurgical system generator FDA UDI
- Device Name
- Electrosurgical Generator with Integrated Smoke Evacuation System, 230 VAC FDA UDI
- Model / Reference
- Finesse II+, 230VAC FDA UDI
- Description
- Electrosurgical Generator with Integrated Smoke Evacuation System, 230 VAC FDA UDI
Identifiers
- Catalog Number
- FIN2-220 FDA UDI
- Primary DI / UDI-DI
- H671FIN22200 FDA UDI
- 510(k) Number
- K123310 FDA UDI
- FDA Product Code
- GEI FDA UDIHGI FDA UDI
- GMDN Term
- Electrosurgical system generator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 FDA UDI884.4120 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 system generator
Finesse by Utah Medical Products, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
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
- Utah Medical Products, Inc.
Sources (1)
- FDA UDI 8d8c914e-1591-4f8c-8a27-d04d1344729a 38 fields · synced Jun 9, 2026