| Primary Device ID | 00852306007753 |
| NIH Device Record Key | 81e2434e-7772-4abc-991d-9d2946ec3b13 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OMNIGUIDE BeamPath OTO-U Fiber |
| Version Model Number | OTO-U |
| Catalog Number | OTO-U |
| Company DUNS | 030124221 |
| Company Name | OMNIGUIDE, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00852306007753 [Primary] |
| GEX | Powered Laser Surgical Instrument |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-04-16 |
| Device Publish Date | 2025-04-08 |
| 00852306007753 - OMNIGUIDE BeamPath OTO-U Fiber | 2025-04-16Laser Fiber |
| 00852306007753 - OMNIGUIDE BeamPath OTO-U Fiber | 2025-04-16 Laser Fiber |
| 00894338002672 - BeamPath NEURO-L Fiber | 2021-04-07 Laser Fiber |
| 00894338002818 - BeamPath ROBOTIC fiber | 2021-04-07 Laser Fiber |
| 00894338002825 - Elevate™ ENT Elite Fiber | 2021-04-07 Laser Fiber |
| 00894338002849 - Omniguide Select Fiber | 2021-04-07 Laser Fiber |
| 00894338002856 - Velocity™ High Performance Fiber | 2021-04-07 Laser Fiber |
| 00852306007708 - TRIO Handpiece | 2019-06-14 The OmniGuide TRIO multi-functional handpiece combines three fundamental surgical functions into one lightweight and compact han |
| 00852306007715 - Beacon Advanced Energy CO2 Laser System | 2019-06-06 A 30 watt Beacon Advanced Energy CO2 Laser System for Surgical use with ability to use line of sight laser energy or fiber suppl |