| Primary Device ID | 00860003321751 |
| NIH Device Record Key | d46173b5-09e5-4f99-943e-95512d7fab9f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OrthoFX Rescue Aligner |
| Version Model Number | RA1 |
| Company DUNS | 033755180 |
| Company Name | ORTHOFX |
| 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 | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860003321751 [Primary] |
| NXC | Aligner, Sequential |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-09-03 |
| Device Publish Date | 2020-08-26 |
| 00860003321799 - OrthoFX Aligner | 2023-10-09 FXTetra Clear Aligner 2.0 |
| 00860003321782 - OrthoFX NiTime Aligner | 2023-09-29 |
| 00860003321775 - OrthoFX | 2021-08-13 Boil and Bite Home Impression Kit. |
| 00860003321765 - OrthoFX | 2021-05-07 Tetra Bright Aligners Tetra Bright Aligners appears to whiten teeth while correcting dentition. |
| 00086000332174 - OrthoFX | 2021-05-06 Tetra Bright Aligners Tetra Bright Aligners appears to whiten teeth while correcting dentition. |
| 00860003321713 - OrthoFX | 2020-12-02 OrthoFX Retainer |
| 00860003321720 - Glo Science | 2020-12-02 Over the counter teeth whitening gel |
| 00860003321737 - OrthoFX | 2020-12-02 OrthoFX Retainer |