PhotonGuide
Illuminator, Narrow/Flat
2manufacturers in China registered for this device type
4catalogue 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 | Stryker GmbH, Switzerland |
|---|---|
| FDA product code | FSZ |
| Device type | Light, Surgical, Carrier |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4580 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2019-06-03 |
| Record revised | 2022-09-26 (version 7) |
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 |
| Storage | Storage environment humidity 10 to 90 % RH; Storage environment atmospheric pressure 50 to 106 KiloPascal; Storage environment temperature -20 to 50 °C; Handling environment atmospheric pressure 70 to 106 KiloPascal; Handling environment temperature 10 to 27 °C; Handling environment humidity 10 to 85 % RH |
| Distribution end date | 2022-07-25 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Narrow / Flat | In distribution | |
| Wide / Flat | In distribution | |
| Wide / Flat | Withdrawn | |
| Narrow / Flat | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| PhotonGuide | Invuity, Inc. | 3 |
| TracLux | Sunoptic Technologies, LLC | 2 |
| 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.