| Primary Device ID | 00192029051108 |
| NIH Device Record Key | d1be26bd-f959-4a5a-b270-3b5c4fbc4f1c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Tip-Edge PLUS Stainless Steel Brackets |
| Version Model Number | 296-6902 |
| 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 | false |
| 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(800)348-8856 |
| nicholas.smith@tportho.com | |
| Phone | +1(800)348-8856 |
| nicholas.smith@tportho.com | |
| Phone | +1(800)348-8856 |
| nicholas.smith@tportho.com | |
| Phone | +1(800)348-8856 |
| nicholas.smith@tportho.com | |
| Phone | +1(800)348-8856 |
| nicholas.smith@tportho.com | |
| Phone | +1(800)348-8856 |
| nicholas.smith@tportho.com | |
| Phone | +1(800)348-8856 |
| nicholas.smith@tportho.com | |
| Phone | +1(800)348-8856 |
| nicholas.smith@tportho.com | |
| Phone | +1(800)348-8856 |
| nicholas.smith@tportho.com | |
| Phone | +1(800)348-8856 |
| nicholas.smith@tportho.com | |
| Phone | +1(800)348-8856 |
| nicholas.smith@tportho.com | |
| Phone | +1(800)348-8856 |
| nicholas.smith@tportho.com | |
| Phone | +1(800)348-8856 |
| nicholas.smith@tportho.com | |
| Phone | +1(800)348-8856 |
| nicholas.smith@tportho.com | |
| Phone | +1(800)348-8856 |
| nicholas.smith@tportho.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00192029051108 [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 | 2025-02-12 |
| Device Publish Date | 2025-02-04 |
| 00192029017456 | UP BI CW W JIGS 4.5 mm |
| 00192029017449 | UP BI CCW W JIGS 4.5 mm |
| 00192029017432 | UP BI CW W JIGS 3.5 mm |
| 00192029017425 | UP BI CCW W JIGS 3.5 mm |
| 00192029017418 | LO BI CW W JIGS 4.5 mm |
| 00192029017401 | LO BI CCW W JIGS 4.5 mm |
| 00192029017395 | LO BI CW W JIGS 3.5 mm |
| 00192029017388 | LO BI CCW W JIGS 3.5 mm |
| 00192029017371 | LO BI CW W JIGS 4.5 mm |
| 00192029017364 | LO BI CCW W JIGS 4.5 mm |
| 00192029017357 | UR CEN W JIGS 3.5 mm |
| 00192029017340 | UL CEN W JIGS 3.5 mm |
| 00192029017333 | Patient Kit 4 BI EXT |
| 00192029017326 | Patient Kit UP/LO EXT W Jigs |
| 00192029017319 | Patient Kit UP/LO 5-5 W Tubes/ |
| 00192029017302 | Patient Kit UP/LO 5-5 W Tubes |
| 00192029011683 | Patient Kit SPEC JIG LO OF |
| 00192029011676 | LO BI CW W JIGS 4.0 mm |
| 00192029011669 | LO BI CW W UNIV JIGS |
| 00192029011645 | UR CUS W JIGS 4.0 mm |
| 00192029011638 | UL CUS W JIGS 4.0 mm |
| 00192029011621 | LO BI CCW W JIGS 4.0 mm |
| 00192029011607 | Upper Bicuspid - CW -7 Torque, 0 |
| 00192029011591 | Upper Bicuspid - CCW -7 Torque, 0 |
| 00192029011577 | UR CUS W JIGS 5.0 mm |
| 00192029011560 | UL CUS W JIGS 5.0 mm |
| 00192029011553 | UR CEN W JIGS 4.5 mm |
| 00192029011546 | UL CEN W JIGS 4.5 mm |
| 00192029011492 | UR LAT W JIGS 4.0 mm |
| 00192029011478 | LO BI CCW W UNIV JIGS |
| 00192029011423 | LO BI CW |
| 00192029011409 | LO BI CCW |
| 00192029011393 | LR CUS W JIGS 5.0 mm |
| 00192029011386 | LL CUS W JIGS 5.0 mm |
| 00192029011379 | LR CUS W JIGS 4.5 mm |
| 00192029011362 | LL CUS W JIGS 4.5 mm |
| 00192029011355 | UR CUS W JIGS 4.5 mm |
| 00192029011348 | UL CUS W JIGS 4.5 mm |
| 00192029011331 | LO BI CW W JIGS 4.0 mm |
| 00192029011324 | LO BI CCW W JIGS 4.0 mm |
| 00192029011317 | LR CUS W JIGS 4.0 mm |
| 00192029011300 | LL CUS W JIGS 4.0 mm |
| 00192029011294 | LR ANT W JIGS 4.0 mm |
| 00192029011287 | LL ANT W JIGS 4.0 mm |
| 00192029011270 | UP BI CW W JIGS 4.0 mm |
| 00192029011263 | UP BI CCW W JIGS 4.0 mm |
| 00192029011256 | UR CEN W JIGS 4.0 mm |
| 00192029011249 | UL CEN W JIGS 4.0 mm |
| 00192029011232 | LO BI CW W JIGS 3.5 mm |
| 00192029011225 | LO BI CCW W JIGS 3.5 mm |