| Primary Device ID | 00190730083159 |
| NIH Device Record Key | f5cba6da-a6e6-4212-a01b-eebfb686eb77 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TruFit 2.0 |
| Version Model Number | 495-00-4600-410 |
| Company DUNS | 781772017 |
| Company Name | ORTHO TECHNOLOGY, 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 | true |
| Expiration Date | false |
| 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 | 00190730083159 [Primary] |
| ECM | BAND, PREFORMED, 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 | 2021-09-08 |
| Device Publish Date | 2021-08-31 |
| 00190730083210 | TruFit 2.0 Molar Band LL6 Size: 44 (3PK) |
| 00190730083203 | TruFit 2.0 Molar Band LL6 Size: 43.5 (3PK) |
| 00190730083197 | TruFit 2.0 Molar Band LL6 Size: 43 (3PK) |
| 00190730083180 | TruFit 2.0 Molar Band LL6 Size: 42.5 (3PK) |
| 00190730083173 | TruFit 2.0 Molar Band LL6 Size: 42 (3PK) |
| 00190730083166 | TruFit 2.0 Molar Band LL6 Size: 41.5 (3PK) |
| 00190730083159 | TruFit 2.0 Molar Band LL6 Size: 41 (3PK) |
| 00190730083142 | TruFit 2.0 Molar Band LL6 Size: 40.5 (3PK) |
| 00190730083135 | TruFit 2.0 Molar Band LL6 Size: 40 (3PK) |
| 00190730083128 | TruFit 2.0 Molar Band LL6 Size: 39.5 (3PK) |
| 00190730083111 | TruFit 2.0 Molar Band LL6 Size: 39 (3PK) |
| 00190730083104 | TruFit 2.0 Molar Band LL6 Size: 38.5 (3PK) |
| 00190730083098 | TruFit 2.0 Molar Band LL6 Size: 38 (3PK) |
| 00190730083081 | TruFit 2.0 Molar Band LL6 Size: 37.5 (3PK) |
| 00190730083074 | TruFit 2.0 Molar Band LL6 Size: 37 (3PK) |
| 00190730083067 | TruFit 2.0 Molar Band LL6 Size: 36.5 (3PK) |
| 00190730083050 | TruFit 2.0 Molar Band LL6 Size: 36 (3PK) |
| 00190730083043 | TruFit 2.0 Molar Band LL6 Size: 35.5 (3PK) |
| 00190730083036 | TruFit 2.0 Molar Band LL6 Size: 35 (3PK) |
| 00190730083029 | TruFit 2.0 Molar Band LL6 Size: 34.5 (3PK) |
| 00190730083012 | TruFit 2.0 Molar Band LL6 Size: 34 (3PK) |
| 00190730083005 | TruFit 2.0 Molar Band LL6 Size: 33.5 (3PK) |
| 00190730082992 | TruFit 2.0 Molar Band LL6 Size: 33 (3PK) |
| 00190730082985 | TruFit 2.0 Molar Band LL6 Size: 32.5 (3PK) |
| 00190730082978 | TruFit 2.0 Molar Band LL6 Size: 32 (3PK) |
| 00190730082961 | TruFit 2.0 Molar Band LL6 Size: 31.5 (3PK) |
| 00190730082954 | TruFit 2.0 Molar Band LL6 Size: 31 (3PK) |
| 00190730082947 | TruFit 2.0 Molar Band LL6 Size: 30.5 (3PK) |
| 00190730082930 | TruFit 2.0 Molar Band LL6 Size: 30 (3PK) |
| 00190730082923 | TruFit 2.0 Molar Band LL6 Size: 29.5 (3PK) |
| 00190730082916 | TruFit 2.0 Molar Band LR6 Size: 44 (3PK) |
| 00190730082909 | TruFit 2.0 Molar Band LR6 Size: 43.5 (3PK) |
| 00190730082893 | TruFit 2.0 Molar Band LR6 Size: 43 (3PK) |
| 00190730082886 | TruFit 2.0 Molar Band LR6 Size: 42.5 (3PK) |
| 00190730082879 | TruFit 2.0 Molar Band LR6 Size: 42 (3PK) |
| 00190730082862 | TruFit 2.0 Molar Band LR6 Size: 41.5 (3PK) |
| 00190730082855 | TruFit 2.0 Molar Band LR6 Size: 41 (3PK) |
| 00190730082848 | TruFit 2.0 Molar Band LR6 Size: 40.5 (3PK) |
| 00190730082831 | TruFit 2.0 Molar Band LR6 Size: 40 (3PK) |
| 00190730082824 | TruFit 2.0 Molar Band LR6 Size: 39.5 (3PK) |
| 00190730082817 | TruFit 2.0 Molar Band LR6 Size: 39 (3PK) |
| 00190730082800 | TruFit 2.0 Molar Band LR6 Size: 38.5 (3PK) |
| 00190730082794 | TruFit 2.0 Molar Band LR6 Size: 38 (3PK) |
| 00190730082787 | TruFit 2.0 Molar Band LR6 Size: 37.5 (3PK) |
| 00190730082770 | TruFit 2.0 Molar Band LR6 Size: 37 (3PK) |
| 00190730082763 | TruFit 2.0 Molar Band LR6 Size: 36.5 (3PK) |
| 00190730082756 | TruFit 2.0 Molar Band LR6 Size: 36 (3PK) |
| 00190730082749 | TruFit 2.0 Molar Band LR6 Size: 35.5 (3PK) |
| 00190730082732 | TruFit 2.0 Molar Band LR6 Size: 35 (3PK) |
| 00190730082725 | TruFit 2.0 Molar Band LR6 Size: 34.5 (3PK) |