| Primary Device ID | 00816728020103 |
| NIH Device Record Key | 680205bb-9d13-42be-b51f-7c5ec900e889 |
| Commercial Distribution Discontinuation | 2019-01-02 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | PhotonGuide XT System |
| Version Model Number | Narrow / Flat |
| Catalog Number | 104008XT |
| Company DUNS | 175697908 |
| Company Name | INVUITY, INC. |
| 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 8667117768 |
| customerservice@invuity.com | |
| Phone | 8667117768 |
| customerservice@invuity.com | |
| Phone | 8667117768 |
| customerservice@invuity.com |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00816728020103 [Primary] |
| FDG | Retractor, Fiberoptic |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-04-24 |
| Device Publish Date | 2016-09-22 |
| 00816728020110 | The PhotonGuide XT System is intended to provide surgical site illumination from a high intensit |
| 00816728020103 | The PhotonGuide XT System is intended to provide surgical site illumination from a high intensit |