TracLux
TRACLUX Light Carrier, Sterile, Single Use, and accessories
2manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
Concentrated in Shandong (1), Guangdong (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Shenzhen Kaiyan Medical Equipment Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 17 |
Record
| Listed by | Sunoptic Technologies, LLC, United States |
|---|---|
| FDA product code | FSZ |
| Device type | Light, Surgical, Carrier |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4580 |
| Establishment | Contract manufacturer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-05-29 |
| Record revised | 2026-03-19 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Pack of 5, pack of 20 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TracLux-SLS | In distribution | |
| TLC | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| PhotonGuide | Stryker GmbH | 4 |
| PhotonGuide | Invuity, Inc. | 3 |
| Light, Surgical, Carrier | Medtronic Sofamor Danek, Inc. | 1 |
| PhotonGuide Adapt | Invuity, Inc. | 1 |
| PhotonGuide Adapt | Stryker GmbH | 1 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.