| Primary Device ID | 06430046260832 |
| NIH Device Record Key | 112bffb3-eb65-4864-8f53-45fa56d29d42 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Signal Camera |
| Version Model Number | 41001595 |
| Company DUNS | 401968495 |
| Company Name | Optomed Oy |
| 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 | true |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06430046260832 [Primary] |
| HKI | Camera, Ophthalmic, Ac-Powered |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-10-08 |
| Device Publish Date | 2019-09-30 |
| 06430046260658 - Pictor M5WEY4ES2 Volk FN | 2021-11-23 Volk Pictor Plus full set |
| 06430046260672 - Pictor M5WEY4 Volk FN | 2021-11-23 Volk Pictor Plus retinal set |
| 06430046260757 - Optomed Aurora full set | 2019-12-12 Aurora full set including Aurora camera, Aurora Retinal module and Aurora Anterior module. |
| 06430046260795 - Optomed Aurora retinal set | 2019-12-12 Optomed Aurora retinal set including Aurora camera and Aurora retinal module. |
| 06430046260870 - Volk Pictor Prestige full set | 2019-12-12 Volk Pictor Prestige full set including Pictor Prestige camera, Pictor Prestige Retina module and Pictor Prestige Anterior modul |
| 06430046260887 - Volk Pictor Prestige retinal set | 2019-12-12 Volk Pictor Prestige retinal set including Pictor Prestige camera and Pictor Prestige retina module. |
| 06430046260856 - Signal set | 2019-10-09 Signal product set including Signal Camera. |
| 06430046260832 - Signal Camera | 2019-10-08Ophthalmic fundus camera |
| 06430046260832 - Signal Camera | 2019-10-08 Ophthalmic fundus camera |