| Primary Device ID | M678NN70640 |
| NIH Device Record Key | 26e49fd7-9ab4-4431-a7e8-a18789a3b4a6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NICO Myriad-LX |
| Version Model Number | TX350A |
| Catalog Number | NN-7064 |
| 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 | 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 | 904-737-7611 |
| Robert.Archie@sunoptictech.com | |
| Phone | 904-737-7611 |
| Robert.Archie@sunoptictech.com | |
| Phone | 904-737-7611 |
| Robert.Archie@sunoptictech.com | |
| Phone | 904-737-7611 |
| Robert.Archie@sunoptictech.com | |
| Phone | 904-737-7611 |
| Robert.Archie@sunoptictech.com | |
| Phone | 904-737-7611 |
| Robert.Archie@sunoptictech.com | |
| Phone | 904-737-7611 |
| Robert.Archie@sunoptictech.com | |
| Phone | 904-737-7611 |
| Robert.Archie@sunoptictech.com | |
| Phone | 904-737-7611 |
| Robert.Archie@sunoptictech.com | |
| Phone | 904-737-7611 |
| Robert.Archie@sunoptictech.com | |
| Phone | 904-737-7611 |
| Robert.Archie@sunoptictech.com | |
| Phone | 904-737-7611 |
| Robert.Archie@sunoptictech.com | |
| Phone | 904-737-7611 |
| Robert.Archie@sunoptictech.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M678NN70640 [Primary] |
| FSS | Light, Surgical, Floor Standing |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-04-04 |
| Device Publish Date | 2025-03-27 |
| M678NN70640 | 300-watt Xenon Light Source, Analog |
| 00855373008036 | 300-Watt Xenon Light Source, Analog |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() NICO MYRIAD-LX 88257262 not registered Live/Pending |
Nico Corporation 2019-01-10 |