| Primary Device ID | 00852306007715 |
| NIH Device Record Key | 8ff38e0d-cbcb-4803-b993-e0e484bc10b6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Beacon Advanced Energy CO2 Laser System |
| Version Model Number | 60 Watt |
| Catalog Number | 420060-AA |
| 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 | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 888-666-4484 |
| customerservice@omni-guide.com |
| Storage Environment Temperature | Between -30 Degrees Celsius and 70 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00852306007715 [Primary] |
| GEX | Powered Laser Surgical Instrument |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2019-06-06 |
| Device Publish Date | 2018-07-02 |
| 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 | 2019-06-06A 30 watt Beacon Advanced Energy CO2 Laser System for Surgical use with ability to use line of sight laser energy or fiber supplied laser energy for use with the OmniGuide waveguide laser fiber |
| 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 |
| 10894338002693 - Gas Filter Unit | 2018-07-06 Gas Filter Unit, Box of 10 |