| Primary Device ID | 00192029046067 |
| NIH Device Record Key | 3226f939-a0ac-4a79-b68e-f573142382df |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Nu-Edge Bracket |
| Version Model Number | 293-1641 |
| 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 |
| matt.oswald@tportho.com | |
| Phone | +1(219)785-2591 |
| matt.oswald@tportho.com | |
| Phone | +1(219)785-2591 |
| matt.oswald@tportho.com | |
| Phone | +1(219)785-2591 |
| matt.oswald@tportho.com | |
| Phone | +1(219)785-2591 |
| matt.oswald@tportho.com | |
| Phone | +1(219)785-2591 |
| matt.oswald@tportho.com | |
| Phone | +1(219)785-2591 |
| matt.oswald@tportho.com | |
| Phone | +1(219)785-2591 |
| matt.oswald@tportho.com | |
| Phone | +1(219)785-2591 |
| matt.oswald@tportho.com | |
| Phone | +1(219)785-2591 |
| matt.oswald@tportho.com | |
| Phone | +1(219)785-2591 |
| matt.oswald@tportho.com | |
| Phone | +1(219)785-2591 |
| matt.oswald@tportho.com | |
| Phone | +1(219)785-2591 |
| matt.oswald@tportho.com | |
| Phone | +1(219)785-2591 |
| matt.oswald@tportho.com | |
| Phone | +1(219)785-2591 |
| matt.oswald@tportho.com | |
| Phone | +1(219)785-2591 |
| matt.oswald@tportho.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00192029046067 [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 |
| 00192029046760 | LO UNIV 1st BI NO HK VERTICAL SLOT |
| 00192029046647 | LR 2nd BI W/DISTAL HK VERTICAL SLOT |
| 00192029046630 | LL 2nd BI W/DISTAL HK VERTICAL SLOT |
| 00192029046586 | LR 1st BI W/DISTAL HK VERTICAL SLOT |
| 00192029046579 | LL 1st BI W/DISTAL HK VERTICAL SLOT |
| 00192029046562 | LO UNIV 1st BI NO HK VERTICAL SLOT |
| 00192029046517 | LL CUS W/DISTAL HK VERTICAL SLOT |
| 00192029046487 | LR CUS NO HK VERTICAL SLOT |
| 00192029046425 | UR BI W/MESIAL HK VERTICAL SLOT |
| 00192029046364 | UR CUS W/DISTAL HK VERTICAL SLOT |
| 00192029046326 | UR CUS NO HK VERTICAL SLOT |
| 00192029046227 | LO UNIV BI NO HK |
| 00192029046173 | UP UNIV BI W 188 BASE NO HK |
| 00192029046128 | UP UNIV CEN |
| 00192029046081 | UL LAT |
| 00192029046074 | UR LAT |
| 00192029046067 | UL LAT |
| 00192029046050 | UR CEN |
| 00192029046043 | UL CEN |
| 00192029045992 | LR 2nd BI W/HK |
| 00192029045985 | LL 2nd BI W/HK |
| 00192029045978 | LR 1st BI W/HK |
| 00192029045954 | LR 1st BI W/HK |
| 00192029045947 | LL 1st BI W/HK |
| 00192029045930 | LO UNIV 2nd BI NO HK |
| 00192029045916 | LO UNIV 1st BI NO HK |
| 00192029023969 | LO UNIV 2nd BI NO HK VERTICAL SLOT |
| 00192029023952 | LO UNIV 1st BI NO HK VERTICAL SLOT |
| 00192029023945 | LR 2nd BI W/DISTAL HK VERTICAL SLOT |
| 00192029023938 | LL 2nd BI W/DISTAL HK VERTICAL SLOT |
| 00192029023921 | LR 1st BI W/DISTAL HK VERTICAL SLOT |
| 00192029023914 | LL 1st BI W/DISTAL HK VERTICAL SLOT |
| 00192029023891 | LR 1st BI W/DISTAL HK VERTICAL SLOT |
| 00192029023884 | LL 1st BI W/DISTAL HK VERTICAL SLOT |
| 00192029023860 | LL CUS NO HK VERTICAL SLOT |
| 00192029023846 | UL CUS NO HK VERTICAL SLOT |
| 00192029023839 | UL BI W/HK |
| 00192029023822 | UP UNIV BI W 188 BASE NO HK |
| 00192029023808 | LR 2nd BI W/HK |
| 00192029023792 | LL 2nd BI W/HK |
| 00192029023778 | LL 1st BI W/HK |
| 00192029015599 | LO UNIV 1st BI NO HK VERTICAL SLOT |
| 00192029015582 | LR CUS W/DISTAL HK VERTICAL SLOT |
| 00192029015575 | LL CUS W/DISTAL HK VERTICAL SLOT |
| 00192029015568 | UR CUS W/DISTAL HK VERTICAL SLOT |
| 00192029015551 | UL CUS W/DISTAL HK VERTICAL SLOT |
| 00192029010419 | UR LAT VERTICAL SLOT |
| 00192029010402 | UL LAT VERTICAL SLOT |
| 00192029010396 | LO UNIV 1st BI NO HK VERTICAL SLOT |
| 00192029010358 | LR CUS NO HK |