| Primary Device ID | M678TX0 |
| NIH Device Record Key | db153b01-d736-476f-9acb-e128a7ee8dbc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Sunoptic Technologies |
| Version Model Number | Tx series Xenon Lightsource |
| Company DUNS | 094586898 |
| Company Name | SUNOPTIC TECHNOLOGIES LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M678TX0 [Primary] |
| FSS | Light, Surgical, Floor Standing |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2023-08-08 |
| Device Publish Date | 2017-05-09 |
| 00855373008036 - NICO Myriad-LX | 2025-06-11 300-Watt Xenon Light Source, Analog |
| 00855373008043 - NICO Corporation | 2025-06-11 Replacement 300-Watt Xenon Lamp Module for NICO Myriad-LX Light Source, Part Number NN-7064 |
| 00855373008029 - Stryker | 2025-05-23 LED-2000 Turbo Light Source |
| M678NN70640 - NICO Myriad-LX | 2025-04-04 300-watt Xenon Light Source, Analog |
| M678NN90100 - NICO | 2025-04-04 Replacement Xenon Lamp Module for NICO Myriad-LX, Xenon Light Source, Part Number NN-7064, Model Tx350A |
| M678DLS10 - Sunoptic Technologies | 2024-08-14 LED Rover Disoposable Series |
| M678ROVER0 - Sunoptic Technologies | 2024-08-14 Rover lightsource series |
| M678SLS10 - Sunoptic Technologies | 2024-08-14 LED Rover Disoposable, Non-Sterile Series |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() SUNOPTIC TECHNOLOGIES 86635409 5142450 Live/Registered |
SUNOPTIC TECHNOLOGIES LLC 2015-05-19 |
![]() SUNOPTIC TECHNOLOGIES 76498665 2936700 Live/Registered |
SUNOPTICS TECHNOLOGIES LLC 2003-03-19 |