| Primary Device ID | 00811608014869 |
| NIH Device Record Key | 45707d09-8fd7-40c3-ad3f-f4fee1345df7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Capsulotomy (VLUCAPS) |
| Version Model Number | VLUCAPS |
| Company DUNS | 071125835 |
| Company Name | VOLK OPTICAL INC. |
| 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 | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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 |
| volk@volk.com | |
| Phone | 440-942-6161 |
| volk@volk.com | |
| Phone | 440-942-6161 |
| volk@volk.com | |
| Phone | 440-942-6161 |
| volk@volk.com | |
| Phone | 440-942-6161 |
| volk@volk.com | |
| Phone | 440-942-6161 |
| volk@volk.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00811608014869 [Primary] |
| HJK | Lens, Contact, Polymethylmethacrylate, Diagnostic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-02-06 |
| Device Publish Date | 2025-01-29 |
| 00811608014869 - Capsulotomy (VLUCAPS) | 2025-02-06 |
| 00811608014869 - Capsulotomy (VLUCAPS) | 2025-02-06 |
| 00811608015934 - Iridectomy (VLUIRID) | 2025-02-06 |
| 00811608014760 - 20D Limited Edition | 2024-10-04 |
| 00811608014777 - 28D Limited Edition | 2024-10-04 |
| 00811608014784 - Pan Retinal 2.2 Limited Edition | 2024-10-04 |
| 00811608014791 - Digital ClearField Limited Edition | 2024-10-04 |
| 00811608014807 - 78D Limited Edition | 2024-10-04 |
| 00811608014814 - 90D Limited Edition | 2024-10-04 |