| Primary Device ID | D865REF00041 |
| NIH Device Record Key | b965323c-818e-4237-8c4b-88517c003206 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ClearCorrect System |
| Version Model Number | Retainer |
| Catalog Number | REF-04 |
| Company DUNS | 016449078 |
| Company Name | Clearcorrect Operating, LLC |
| 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 | true |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| D865REF0001 | The ClearCorrect device is fabricated of clear thin thermoformed polyeurethane plastic in a sequ |
| D865REF00051 | The ClearCorrect device is fabricated of clear thin thermoformed polyurethane plastic in a seque |
| D865REF00041 | The ClearCorrect retainer device is fabricated of clear thin thermoformed polyurethane plastic a |
| D865REF00031 | The ClearCorrect device is fabricated of thin thermoplastic polyurethane/co-polyester composite |
| D865REF00021 | Engager template device accessory for use with the ClearCorrect System. |
| D865REF00011 | The ClearCorrect device is fabricated of clear thin thermoformed polyeurethane plastic in a sequ |
| D865REF05001 | The ClearCorrect device is fabricated of clear thin thermoformed polyurethane plastic in a seque |
| D865REF04001 | The ClearCorrect retainer device is fabricated of clear thin thermoformed polyurethane plastic a |
| D865REF03001 | The ClearCorrect device is fabricated of thin thermoplastic polyurethane/co-polyester composite |
| D865REF02001 | Engager template device accessory for use with the ClearCorrect System. |