FDA UDI
In Commercial Distribution
🇺🇸 United States
TRIO Handpiece
DI: 00852306007708
·
Model: 1
·
OMNIGUIDE, INC.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- TRIO Handpiece
- Primary DI
- 00852306007708
- Version / Model
- 1
- Catalog Number
- 323000
- Company Name
- OMNIGUIDE, INC.
- Labeler DUNS
- 030124221
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-06-06
- Public Version
- 2
- Public Version Date
- 2023-04-04
- Public Version Status
- Update
- Public Device Record Key
- fde2b32e-410b-4cee-a2da-77fbce556dc5
Device 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.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | 878.4400 | 2 |
| GEX | Powered Laser Surgical Instrument | General, Plastic Surgery | 878.4810 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44681 | Electrosurgical handpiece, single-use | A hand-held component of an electrosurgical system intended to provide an electrical connection between the system generator and a detachable electrode at its distal end, enabling the surgeon controlled manipulation of the electrode during surgery; the electrode is not included. The device is typically in the form of a pen with permanently attached cables for connection to a generator; it is not intended for use during inert gas-enhanced electrosurgery. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00852306007708 | GS1 |
Customer Contacts
- Phone
- 888-666-4484
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K183199 | 000 |
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 75 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 30 Degrees Celsius
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 50 – 106 KiloPascal