| Primary Device ID | 00816728021315 |
| NIH Device Record Key | 7ccfc37c-0c0c-4895-b68c-e1b1fcdde69e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PhotonGuide Adapt |
| Version Model Number | PhotonGuide Adapt |
| Catalog Number | PGA1 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00816728020479 [Previous] |
| GS1 | 00816728021315 [Primary] |
| FSZ | Light, Surgical, Carrier |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2020-04-24 |
| Device Publish Date | 2019-04-19 |
| 00816728021315 | The PhotonGuide Adapt is intended to provide surgical site illumination from a high intensity li |
| 00816728020479 | The PhotonGuide Adapt is intended to provide surgical site illumination from a high intensity li |