| Primary Device ID | 00811608013572 |
| NIH Device Record Key | 0696bd47-fb8d-4461-8f02-6bef5806015b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | G-3 Goniofundus NF |
| Version Model Number | VG3NF |
| 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 | false |
| 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 | 440-942-6161 |
| snigdha.katragadda@volk.com | |
| Phone | 440-942-6161 |
| snigdha.katragadda@volk.com | |
| Phone | 440-942-6161 |
| snigdha.katragadda@volk.com | |
| Phone | 440-942-6161 |
| snigdha.katragadda@volk.com | |
| Phone | 440-942-6161 |
| snigdha.katragadda@volk.com | |
| Phone | 440-942-6161 |
| snigdha.katragadda@volk.com | |
| Phone | 440-942-6161 |
| snigdha.katragadda@volk.com | |
| Phone | 440-942-6161 |
| snigdha.katragadda@volk.com | |
| Phone | 440-942-6161 |
| snigdha.katragadda@volk.com | |
| Phone | 440-942-6161 |
| snigdha.katragadda@volk.com | |
| Phone | 440-942-6161 |
| snigdha.katragadda@volk.com | |
| Phone | 440-942-6161 |
| snigdha.katragadda@volk.com | |
| Phone | 440-942-6161 |
| snigdha.katragadda@volk.com | |
| Phone | 440-942-6161 |
| snigdha.katragadda@volk.com | |
| Phone | 440-942-6161 |
| snigdha.katragadda@volk.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00811608013572 [Primary] |
| HKS | Prism, Gonioscopic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-10-05 |
| Device Publish Date | 2020-09-25 |
| 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 |