PhotonGuide XT System
The PhotonGuide XT System is intended to provide surgical site illumination from a high intensity light source.
1manufacturer
2catalogue numbers in this listing
Who Else Makes It
Registered in Shanghai.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
Record
| Listed by | Invuity, Inc., United States |
|---|---|
| FDA product code | FDG |
| Device type | Retractor, Fiberoptic |
| Device class | Class 1 |
| Regulation | 21 CFR 876.4530 |
| Premarket notification | Exempt |
| Record published | 2016-09-22 |
| Record revised | 2020-04-24 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Distribution end date | 2019-01-02 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Narrow / Flat | Angle: Flat | Withdrawn |
| Narrow / Angled | Angle: Angled | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Retractor, Fiberoptic | Black & Black Surgical, Inc. | 48 |
| Carnegie Surgical LLC | Carnegie Surgical LLC | 28 |
| Black & Black Surgical | Black & Black Surgical, Inc. | 20 |
| BR Surgical, LLC | BR Surgical LLC | 18 |
| Snowden-Pencer | Steris Corporation | 14 |
| InnerVision® | Diversatek Healthcare Inc | 10 |
| Boss Instruments | Boss Instruments, Ltd. | 9 |
| Retractor | KLS-Martin L.P. | 9 |
| Novo Surgical | Novo Surgical, Inc. | 8 |
| TSI | Tedan Surgical Innovations, L.L.C. | 8 |
| Lumitex Surgical Light Cable | Lumitex, Inc. | 7 |
| My Medical | MY Medical Store LLC | 7 |
Showing 12 of 186. All products under Retractor, Fiberoptic
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.