| Primary Device ID | 00812056033693 |
| NIH Device Record Key | ab1030ca-7a15-42c6-acf6-c8018ea03527 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EV Collection |
| Version Model Number | EV300 |
| Company DUNS | 154402791 |
| Company Name | ENCORE VISION, 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 | false |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00812056033693 [Primary] |
| HQZ | Frame, Spectacle |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-07-04 |
| Device Publish Date | 2022-06-24 |
| 00812056033730 | Eyeglass Frame,"EV302, Brown/Aqua, 54-19-142" |
| 00812056033723 | Eyeglass Frame,"EV302, Crystal/Black, 54-19-142" |
| 00812056033716 | Eyeglass Frame,"EV301, Purple, 51-18-145" |
| 00812056033709 | Eyeglass Frame,"EV301, Grey, 51-18-145" |
| 00812056033693 | Eyeglass Frame,"EV300, Black/Crystal, 53-16-145" |
| 00812056033686 | Eyeglass Frame,"EV300, Brown/Aqua, 53-16-145" |