| Primary Device ID | 00812056033945 |
| NIH Device Record Key | 52ef6469-0ab5-48de-ad21-abe7b6fb2554 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Twisted |
| Version Model Number | TW203 |
| 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 | 00812056033945 [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 |
| 00812056031521 | Eyeglass Frame,"TW202, Purple/Teal, 54-18-140" |
| 00812056031514 | Eyeglass Frame,"TW202, Black/Fuchsia, 54-18-140" |
| 00812056031507 | Eyeglass Frame,"TW202, Black/Red, 54-18-140" |
| 00812056031491 | Eyeglass Frame,"TW201, Purple/Fuchsia, 53-17-140" |
| 00812056031484 | Eyeglass Frame,"TW201, Brown/Turquoise, 53-17-140" |
| 00812056031477 | Eyeglass Frame,"TW201, Black/Red, 53-17-140" |
| 00812056031460 | Eyeglass Frame,"TW102, Grey/Orange, 50-19-138" |
| 00812056031453 | Eyeglass Frame,"TW102, Black/Silver, 50-19-138" |
| 00812056031446 | Eyeglass Frame,"TW102, Black/Red, 50-19-138" |
| 00812056031439 | Eyeglass Frame,"TW101, Blue/Green, 53-17-138" |
| 00812056031422 | Eyeglass Frame,"TW101, Black/Turquoise, 53-17-138" |
| 00812056031415 | Eyeglass Frame,"TW101, Black/Orange, 53-17-138" |
| 00812056033945 | Eyeglass Frame,"TW203, Brown/Turquoise, 54-18-138" |
| 00812056033938 | Eyeglass Frame,"TW203, Black/Fuchsia, 54-18-138" |