| Primary Device ID | E31593800002000 |
| NIH Device Record Key | d66d07b8-e070-4fb5-9647-5ce6c2135c2c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | StarX-2 |
| Version Model Number | 9380000200 |
| Company DUNS | 514320345 |
| Company Name | FONA SRL |
| 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | E31593800002000 [Primary] |
| MUH | System, X-Ray, Extraoral Source, Digital |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-09-10 |
| Device Publish Date | 2021-09-02 |
| E3158468260320 - FONA ART Plus | 2023-06-20 |
| E3158468463121 - FONA ART Plus C | 2023-06-20 |
| E3158468463221 - FONA ART Plus C | 2023-06-20 |
| E3159319001700 - FONA XDC | 2022-09-14 |
| E3158468600000 - Stellaris 3D | 2022-05-09 |
| E3158468600002 - Stellaris 3D Ceph | 2022-05-09 |
| E3158468600007 - Stellaris 2D | 2022-05-09 |
| E3158468600008 - Stellaris 2D Ceph | 2022-05-09 |