TRACLUX
GUDID M678TLC0
TRACLUX Light Carrier, Sterile, Single Use, and accessories
SUNOPTIC TECHNOLOGIES LLC
Open surgical site internal light source Open surgical site internal light source Open surgical site internal light source Open surgical site internal light source Open surgical site internal light source Open surgical site internal light source Open surgical site internal light source Open surgical site internal light source Open surgical site internal light source Open surgical site internal light source Open surgical site internal light source Open surgical site internal light Open surgical site internal light Open surgical site internal light Open surgical site internal light Open surgical site internal light Open surgical site internal light Open surgical site internal light Open surgical site internal light Open surgical site internal light Open surgical site internal light Open surgical site internal light Open surgical site internal light Open surgical site internal light Open surgical site internal light Open surgical site internal light Open surgical site internal light Open surgical site internal light Open surgical site internal light Open surgical site internal light Open surgical site internal light Open surgical site internal light Open surgical site internal light Open surgical site internal light Open surgical site internal light Open surgical site internal light Open surgical site internal light Open surgical site internal light Open surgical site internal light Open surgical site internal light Open surgical site internal light| 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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