| Primary Device ID | 00192029029596 |
| NIH Device Record Key | 62c7a43d-67ac-479d-9a6d-0a0853f614cc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Rounded Rectangular Wire |
| Version Model Number | 381-397 |
| Company DUNS | 005432299 |
| Company Name | TP ORTHODONTICS 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| 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 | 00192029029596 [Primary] |
| DZC | WIRE, 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 | 2021-03-23 |
| Device Publish Date | 2021-03-15 |
| 00192029029596 | Standard Arch Form Upper |
| 00192029029589 | Standard Arch Form Lower |
| 00192029016213 | 0.48 x 0.66mm (.019" x .026") |
| 00192029016206 | 0.46 x 0.64mm (.018" x .025") |
| 00192029050453 | Bio-Arch III Rectangular |
| 00192029050446 | Straight Arch Form Upper Rectangular |
| 00192029050439 | Straight Arch Form Lower Rectangular |
| 00192029050422 | Straight Arch Form Upper Rectangular |
| 00192029050415 | Straight Arch Form Lower Rectangular |
| 00192029050408 | Straight Arch Form Upper Rectangular |
| 00192029050392 | Straight Arch Form Lower Rectangular |
| 00192029050385 | Straight Arch Form Upper Rectangular |
| 00192029050378 | Straight Arch Form Lower Rectangular |
| 00192029050361 | Straight Arch Form Upper Rectangular |
| 00192029050354 | Straight Arch Form Lower Rectangular |
| 00192029050347 | Bio-Arch III Rectangular |
| 00192029050330 | Bio-Arch III Rectangular |