| Primary Device ID | 10811608014675 |
| NIH Device Record Key | 7c26eec4-00d5-4964-8441-b0710757379a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Single Use Indirect Wide Field (VVITSSVDH) |
| Version Model Number | VVITSSVDH |
| Company DUNS | 071125835 |
| Company Name | VOLK OPTICAL INC. |
| Device Count | 1 |
| DM Exempt | true |
| 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 | 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 | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00811608014654 [Primary] |
| GS1 | 10811608014675 [Package] Contains: 00811608014654 Package: BOX [10 Units] In Commercial Distribution |
| GS1 | 20811608014689 [Package] Contains: 00811608014654 Package: CARTON [100 Units] In Commercial Distribution |
| GS1 | 30811608014693 [Package] Contains: 00811608014654 Package: CASE [400 Units] In Commercial Distribution |
| HJK | Lens, Contact, Polymethylmethacrylate, Diagnostic |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-10-27 |
| Device Publish Date | 2023-10-19 |
| 00811608019802 - Rapid SLT | 2025-08-15 |
| 00811608019819 - 20D Limited Edition #2 | 2025-08-11 |
| 00811608019826 - 28D Limited Edition #2 | 2025-08-11 |
| 00811608019833 - Pan Retinal 2.2 Limited Edition #2 | 2025-08-11 |
| 00811608019840 - 78D Limited Edition #2 | 2025-08-11 |
| 00811608019857 - 90D Limited Edition #2 | 2025-08-11 |
| 00811608019864 - Super 66® Limited Edition #2 | 2025-08-11 |
| 00811608019871 - SuperField® Limited Edition #2 | 2025-08-11 |