TRACLUX
GUDID M678TLC0
TRACLUX Light Carrier, Sterile, Single Use, and accessories
SUNOPTIC TECHNOLOGIES LLC
Open surgical site internal light source| Primary Device ID | M678TLC0 |
| NIH Device Record Key | 268bdd8c-efad-4d18-9ff3-83706df9e392 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TRACLUX |
| Version Model Number | TLC |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M678TLC0 [Primary] |
| HIBCC | M678TLC1 [Package] Package: [5 Units] In Commercial Distribution |
| HIBCC | M678TLC3 [Package] Package: [20 Units] In Commercial Distribution |
FDA Product Code
| FSZ | Light, Surgical, Carrier |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-11-15 |
| Device Publish Date | 2021-11-05 |
On-Brand Devices [TRACLUX]
| M678TLC0 | TRACLUX Light Carrier, Sterile, Single Use, and accessories |
| M678HHR0 | Hand Held Retractor and accessories |
| M678TLCSLS0 | TracLux SLS-S, Battery Operated Lightsource |
Trademark Results [TRACLUX]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TRACLUX 88264209 not registered Live/Pending |
Aculux, Inc. 2019-01-16 |
 TRACLUX 77159612 3343675 Dead/Cancelled |
Aculux, Inc. 2007-04-18 |
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