| Primary Device ID | 00811608018638 |
| NIH Device Record Key | 06dff7d3-1476-4d0a-b9f8-038265d14b1c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Volk Pictor Plus VP2HAND, VP2RET and VP2ANT |
| Version Model Number | VP2OPHK |
| Company DUNS | 071125835 |
| Company Name | VOLK OPTICAL 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 | true |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| 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 |
| Phone | 4409426161 |
| bernie.rykaczewski@volk.com | |
| Phone | 4409426161 |
| bernie.rykaczewski@volk.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00811608018638 [Primary] |
| HKI | Camera, Ophthalmic, Ac-Powered |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-09-29 |
| 00811608014708 - Volk Viva | 2024-04-15 |
| 00811608014739 - Volk Viva | 2024-04-15 |
| 10811608014675 - Single Use Indirect Wide Field (VVITSSVDH) | 2023-10-27 |
| 00811608013770 - Volk VistaView | 2022-11-24 |
| 00811608014586 - VistaView Slit Lamp Adapter | 2022-11-24 |
| 00811608019703 - Virtual by Volk Telemedicine Software | 2021-11-18 |
| 00811608011240 - Digital Wide Field®, Custom Color | 2021-01-25 |
| 00811608011332 - Super 66® Stereo Fundus | 2020-10-05 |