Primary Device ID | 00192029010792 |
NIH Device Record Key | 041a2df1-8205-4f68-87a1-3470aa8f0840 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | RX1 Metal Bracket |
Version Model Number | 296-059 |
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 | 00192029010792 [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 | 2021-02-23 |
Device Publish Date | 2021-02-15 |
00192029017470 | UR CUS W JIGS 5.0 mm Torque -4, Tip +11 |
00192029017463 | UL CUS W JIGS 5.0 mm Torque -4, Tip +11 |
00192029011461 | LR CUS W JIGS 4.5 mm Torque -11, Tip +5 |
00192029011454 | LL CUS W JIGS 4.5 mm Torque -11, Tip +5 |
00192029010808 | UR CUS W JIGS 4.5 mm Torque -4, Tip +11 |
00192029010792 | UL CUS W JIGS 4.5 mm Torque -4, Tip +11 |
00192029010785 | LO BI CW W JIGS 4.0 mm Torque -20, Tip 0 |
00192029010778 | LO BI CCW W JIGS 4.0 mm Torque -20, Tip 0 |
00192029010761 | LR CUS W JIGS 4.0 mm Torque -11, Tip +5 |
00192029010754 | LL CUS W JIGS 4.0 mm Torque -11, Tip +5 |
00192029010747 | UP BI CW W JIGS 4.0 mm Torque -7, Tip 0 |
00192029010730 | UP BI CCW W JIGS 4.0 mm Torque -7, Tip 0 |
00192029010723 | UR CEN W JIGS 4.0 mm Torque +12, Tip +5 |
00192029010716 | UL CEN W JIGS 4.0 mm Torque +12, Tip +5 |
00192029010709 | LR ANT W JIGS 3.5 mm Torque -1, Tip +2 |
00192029010693 | LL ANT W JIGS 3.5 mm Torque -1, Tip +2 |
00192029010662 | UR LAT W JIGS 3.5 mm Torque +8, Tip +9 |
00192029010655 | UL LAT W JIGS 3.5 mm Torque +8, Tip +9 |