| Primary Device ID | 00858848006377 |
| NIH Device Record Key | 509a743b-b39c-4a85-b13f-449411e809d5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | RTVue XR Avanti Scanner |
| Version Model Number | Avanti Scanner |
| Catalog Number | 500-47760-006 |
| Company DUNS | 196500461 |
| Company Name | OPTOVUE, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 866-941-9240 |
| service@optovue.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00858848006377 [Primary] |
| OBO | Tomography, Optical Coherence |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-05-15 |
| 00858848006377 | For use with Optovue RTVue XR Avanti Ophthalmic Optical Coherence Tomography System |
| 00858848006360 | For use with Optovue RTVue XR Avanti Ophthalmic Optical Coherence Tomography System |
| 00858848006353 | For use with Optovue RTVue XR Avanti Ophthalmic Optical Coherence Tomography System |
| 00858848006667 | For use with Optovue RTVue XR Avanti Ophthalmic Optical Coherence Tomography System |