| Primary Device ID | 00192029017579 |
| NIH Device Record Key | 30c82ae8-72ab-4256-8ba3-aaa1d96d3cbc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Tip-Edge SL PLUS Stainless Steel Brackets |
| Version Model Number | 296-617SL |
| 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 | false |
| 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 | 00192029017579 [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 | 2022-10-25 |
| Device Publish Date | 2022-10-17 |
| 00192029017784 | SL TE PLUS LO CW BI 22 4MM |
| 00192029017777 | SL TE PLUS LO CCW BI 22 4MM |
| 00192029017760 | SL TE PLUS LR CUS 22 4MM |
| 00192029017753 | SL TE PLUS LL CUS 22 4MM |
| 00192029017746 | SL TE PLUS LR ANT 22 3.5MM |
| 00192029017739 | SL TE PLUS LL ANT 22 3.5MM |
| 00192029017722 | SL TE PLUS UP CW BI 22 4MM |
| 00192029017715 | SL TE PLUS UP CCW BI 22 4MM |
| 00192029017708 | SL TE PLUS UR CUS 22 4.5MM |
| 00192029017692 | SL TE PLUS UL CUS 22 4.5MM |
| 00192029017685 | SL TE PLUS UR LAT 22 3.5MM |
| 00192029017678 | SL TE PLUS UL LAT 22 3.5MM |
| 00192029017661 | SL TE PLUS UR CEN 22 4MM |
| 00192029017654 | SL TE PLUS UL CEN 22 4MM |
| 00192029017647 | SL TE PLUS LO CW BI 22 |
| 00192029017630 | SL TE PLUS LO CCW BI 22 |
| 00192029017623 | SL TE PLUS LR CUS 22 |
| 00192029017616 | SL TE PLUS LL CUS 22 |
| 00192029017609 | SL TE PLUS LR ANT 22 |
| 00192029017593 | SL TE PLUS LL ANT 22 |
| 00192029017586 | SL TE PLUS UP CW BI 22 |
| 00192029017579 | SL TE PLUS UP CCW BI 22 |
| 00192029017562 | SL TE PLUS UR CUS 22 |
| 00192029017555 | SL TE PLUS UL CUS 22 |
| 00192029017548 | SL TE PLUS UR LAT 22 |
| 00192029017531 | SL TE PLUS UL LAT 22 |
| 00192029017524 | SL TE PLUS UR CEN 22 |
| 00192029017517 | SL TE PLUS UL CEN 22 |
| 00192029017500 | SL PLUS NON EXT 22 KIT OR |
| 00192029017494 | SL PLUS NON EXT 22 KIT |