Primary Device ID | 00192029020517 |
NIH Device Record Key | 6051da95-b608-48d4-ba0a-fbe10c1cf6eb |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Second Molar Single Tubes |
Version Model Number | 391-633 |
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 | |
Phone | +1(800)348-8856 |
nicholas.smith@tportho.com | |
Phone | +1(800)348-8856 |
nicholas.smith@tportho.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00192029020517 [Primary] |
DZD | TUBE, 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 | 2024-11-21 |
Device Publish Date | 2024-11-13 |
00192029020838 | LR 2nd Molar Torque -25, Tip 0, Distal Offset 6 |
00192029020821 | LL 2nd Molar Torque -25, Tip 0, Distal Offset 6 |
00192029020531 | LR 2nd Molar Mini Size Torque -10, Tip 0, Distal Offset 0 |
00192029020524 | LL 2nd Molar Mini Size Torque -10, Tip 0, Distal Offset 0 |
00192029020500 | UL 2nd Molar Mini Size Torque -14, Tip 0, Distal Offset 10 |
00192029019832 | UL 2nd Molar W/O Distal Extension Torque -14, Tip 0, Distal Offset 14 |
00192029019825 | UR 2nd Molar W/O Distal Extension Torque -14, Tip 0, Distal Offset 14 |
00192029019818 | UL 2nd Molar W/O Distal Extension Torque -10, Tip 0, Distal Offset 14 |
00192029019801 | UR 2nd Molar W/O Distal Extension Torque -10, Tip 0, Distal Offset 14 |
00192029019771 | UL 2nd Molar W/O Distal Extension Torque -10, Tip 0, Distal Offset 14 |
00192029019764 | UR 2nd Molar W/O Distal Extension Torque -10, Tip 0, Distal Offset 14 |
00192029019757 | LL 2nd Molar W/O Distal Extension Torque -30, Tip 0, Distal Offset 4 |
00192029019740 | LR 2nd Molar W/O Distal Extension Torque -30, Tip 0, Distal Offset 4 |
00192029019658 | LL 2nd Molar W/O Distal Extension Torque -25, Tip 0, Distal Offset 4 |
00192029019641 | LR 2nd Molar W/O Distal Extension Torque -25, Tip 0, Distal Offset 4 |
00192029019634 | LL 2nd Molar W/O Distal Extension Torque -25, Tip 0, Distal Offset 4 |
00192029019627 | LR 2nd Molar W/O Distal Extension Torque -25, Tip 0, Distal Offset 4 |
00192029013526 | UR 2nd Molar Torque -10, Tip 0, Distal Offset 6 |
00192029013519 | UL 2nd Molar Torque -10, Tip 0, Distal Offset 6 |
00192029013403 | LR 2nd Molar Mini Size Torque -10, Tip 0, Distal Offset 0 |
00192029013397 | LL 2nd Molar Mini Size Torque -10, Tip 0, Distal Offset 0 |
00192029013380 | UR 2nd Molar Mini Size Torque -14, Tip 0, Distal Offset 10 |
00192029013373 | UL 2nd Molar Mini Size Torque -14, Tip 0, Distal Offset 10 |
00192029020517 | UR 2nd Molar Mini Size Torque -14, Tip 0, Distal Offset 10 0.46 mm 0.64 mm (.018"x .025") 2.3 mm |