| Primary Device ID | 00192029019191 |
| NIH Device Record Key | c032b9c0-ea41-4729-8ee6-8c0a6d98a39b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Nu-Edge Self-Ligating CoCr Brackets |
| Version Model Number | 293-085SL |
| 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 |
| Phone | +1(219)785-2591 |
| nicholas.smith@tportho.com | |
| Phone | +1(219)785-2591 |
| nicholas.smith@tportho.com | |
| Phone | +1(219)785-2591 |
| nicholas.smith@tportho.com | |
| Phone | +1(219)785-2591 |
| nicholas.smith@tportho.com | |
| Phone | +1(219)785-2591 |
| nicholas.smith@tportho.com | |
| Phone | +1(219)785-2591 |
| nicholas.smith@tportho.com | |
| Phone | +1(219)785-2591 |
| nicholas.smith@tportho.com | |
| Phone | +1(219)785-2591 |
| nicholas.smith@tportho.com | |
| Phone | +1(219)785-2591 |
| nicholas.smith@tportho.com | |
| Phone | +1(219)785-2591 |
| nicholas.smith@tportho.com | |
| Phone | +1(219)785-2591 |
| nicholas.smith@tportho.com | |
| Phone | +1(219)785-2591 |
| nicholas.smith@tportho.com | |
| Phone | +1(219)785-2591 |
| nicholas.smith@tportho.com | |
| Phone | +1(219)785-2591 |
| nicholas.smith@tportho.com | |
| Phone | +1(219)785-2591 |
| nicholas.smith@tportho.com | |
| Phone | +1(219)785-2591 |
| nicholas.smith@tportho.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00192029019191 [Primary] |
| EJF | BRACKET, METAL, 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 | 2022-02-09 |
| Device Publish Date | 2022-02-01 |