| Primary Device ID | D866HCCY40BB0 |
| NIH Device Record Key | ce19547e-4e69-46b9-bb2a-d1cff8613d34 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Ortho-Tain, Inc |
| Version Model Number | HABIT CORRECTOR |
| Catalog Number | HC |
| Company DUNS | 090557638 |
| Company Name | Ortho-Tain, Inc |
| Device Count | 1 |
| DM Exempt | true |
| 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 | true |
| Lot Batch | true |
| 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 |
|---|---|
| HIBCC | D866HCCY40BB0 [Primary] |
| DYO | Band, Material, Orthodontic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-05-20 |
| Device Publish Date | 2025-05-12 |
| D866HCCY40B0 | YOUTH HABIT CORRECTOR CLOSE |
| D866HCCP40B0 | KIDS HABIT CORRECTOR NO PADS |
| D866HCCY40BPK0 | YOUTH HABIT CORRECTOR CLOSE - PINK |
| D866HCCY40BO0 | YOUTH HABIT CORRECTOR CLOSE - ORANGE |
| D866HCCY40BG0 | YOUTH HABIT CORRECTOR CLOSE - GREEN |
| D866HCCY40BB0 | YOUTH HABIT CORRECTOR CLOSE - BLUE |
| D866HCCY40B0P0 | YOUTH HABIT CORRECTOR CLOSE - PURPLE |
| D866HCCSK40ANPK0 | SLENDERIZED KIDS+ HC - PINK |
| D866HCCSK40ANP0 | SLENDERIZED KIDS+ HC - PURPLE |
| D866HCCSK40ANO0 | SLENDERIZED KIDS+ HC - ORANGE |
| D866HCCSK40ANG0 | SLENDERIZED KIDS+ HC - GREEN |
| D866HCCSK40ANB0 | SLENDERIZED KIDS+ HC - BLUE |
| D866HCCP40BPK0 | KIDS HABIT CORRECTOR NO PADS - PINK |
| D866HCCP40BO0 | KIDS HABIT CORRECTOR NO PADS - ORANGE |
| D866HCCP40BG0 | KIDS HABIT CORRECTOR NO PADS - GREEN |
| D866HCCP40BB0 | KIDS HABIT CORRECTOR NO PADS - BLUE |
| D866HCCP40B0P0 | KIDS HABIT CORRECTOR NO PADS - PURPLE |