Identity
- Trade Name
- TRIO Handpiece FDA UDI
- Generic Name
- Electrosurgical handpiece, single-use FDA UDI
- Device Name
- The OmniGuide TRIO multi-functional handpiece combines three fundamental surgical functions into one lightweight and compact handheld disposable surgical instrument. It enables a surgeon to provide fluid suction, bipolar cautery and CO2 laser energy delivered via a flexible OmniGuide fiber for minimally invasive surgery. The handpiece is delivered sterile, and is intended for one-time use only. TRIO has been validated to be used with the Valleylab Triad or Valleylab Force FX. FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- The OmniGuide TRIO multi-functional handpiece combines three fundamental surgical functions into one lightweight and compact handheld disposable surgical instrument. It enables a surgeon to provide fluid suction, bipolar cautery and CO2 laser energy delivered via a flexible OmniGuide fiber for minimally invasive surgery. The handpiece is delivered sterile, and is intended for one-time use only. TRIO has been validated to be used with the Valleylab Triad or Valleylab Force FX. FDA UDI
Identifiers
- Catalog Number
- 323000 FDA UDI
- Primary DI / UDI-DI
- 00852306007708 FDA UDI
- 510(k) Number
- K183199 FDA UDI
- FDA Product Code
- GEI FDA UDIGEX FDA UDI
- GMDN Term
- Electrosurgical handpiece, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 FDA UDI878.4810 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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Electrosurgical handpiece, single-use
TRIO Handpiece by Omniguide, Inc. — 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
- Omniguide, Inc.
Sources (1)
- FDA UDI fde2b32e-410b-4cee-a2da-77fbce556dc5 37 fields · synced May 30, 2026