| Primary Device ID | 10811608019946 |
| NIH Device Record Key | db92a772-40d0-43bf-afe5-46320b85ea54 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Single Use GonioPro Surgical Lens + Handle (VSGLHD) |
| Version Model Number | VSGLHD |
| Company DUNS | 071125835 |
| Company Name | VOLK OPTICAL INC. |
| Device Count | 1 |
| DM Exempt | true |
| 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 | 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 | 00811608019949 [Primary] |
| GS1 | 10811608019946 [Package] Contains: 00811608019949 Package: Box [10 Units] In Commercial Distribution |
| GS1 | 20811608019943 [Package] Contains: 00811608019949 Package: Carton [100 Units] In Commercial Distribution |
| GS1 | 30811608019940 [Package] Contains: 00811608019949 Package: Case [400 Units] In Commercial Distribution |
| HKS | Prism, Gonioscopic |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-02-12 |
| Device Publish Date | 2026-02-04 |
| 00811608019895 - GonioPro Surgical Lens + Handle (VSGLHACS) | 2026-02-12 |
| 10811608019908 - Single Use GonioPro Surgical Single-Port Stabilizer (VSGSAD) | 2026-02-12 |
| 10811608019915 - Single Use GonioPro Surgical Multi-Port Stabilizer (VSGSBD) | 2026-02-12 |
| 10811608019922 - Single Use GonioPro Surgical Lens + Single-Port Stabilizer (VSGLSAD) | 2026-02-12 |
| 10811608019939 - Single Use GonioPro Surgical Lens + Multi-Port Stabilizer (VSGLSBD) | 2026-02-12 |
| 10811608019946 - Single Use GonioPro Surgical Lens + Handle (VSGLHD) | 2026-02-12 |
| 10811608019946 - Single Use GonioPro Surgical Lens + Handle (VSGLHD) | 2026-02-12 |
| 00811608019802 - Rapid SLT | 2025-08-15 |
| 00811608019819 - 20D Limited Edition #2 | 2025-08-11 |