RX1 Metal Bracket

GUDID 00192029010747

UP BI CW W JIGS 4.0 mm Torque -7, Tip 0 0.56 mm (0.022")

TP ORTHODONTICS INC

Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal
Primary Device ID00192029010747
NIH Device Record Keyb0fc3d88-cea9-4db7-98e5-8c64c6f18b56
Commercial Distribution StatusIn Commercial Distribution
Brand NameRX1 Metal Bracket
Version Model Number296-046
Company DUNS005432299
Company NameTP ORTHODONTICS INC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100192029010747 [Primary]
GS100192029010747 [Primary]
GS100192029010747 [Primary]
GS100192029010747 [Primary]
GS100192029010747 [Primary]
GS100192029010747 [Primary]
GS100192029010747 [Primary]
GS100192029010747 [Primary]
GS100192029010747 [Primary]
GS100192029010747 [Primary]
GS100192029010747 [Primary]
GS100192029010747 [Primary]
GS100192029010747 [Primary]
GS100192029010747 [Primary]
GS100192029010747 [Primary]
GS100192029010747 [Primary]

FDA Product Code

EJFBRACKET, METAL, ORTHODONTIC
EJFBRACKET, METAL, ORTHODONTIC
EJFBRACKET, METAL, ORTHODONTIC
EJFBRACKET, METAL, ORTHODONTIC
EJFBRACKET, METAL, ORTHODONTIC
EJFBRACKET, METAL, ORTHODONTIC
EJFBRACKET, METAL, ORTHODONTIC
EJFBRACKET, METAL, ORTHODONTIC
EJFBRACKET, METAL, ORTHODONTIC
EJFBRACKET, METAL, ORTHODONTIC
EJFBRACKET, METAL, ORTHODONTIC
EJFBRACKET, METAL, ORTHODONTIC
EJFBRACKET, METAL, ORTHODONTIC
EJFBRACKET, METAL, ORTHODONTIC
EJFBRACKET, METAL, ORTHODONTIC
EJFBRACKET, METAL, ORTHODONTIC

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-02-23
Device Publish Date2021-02-15

On-Brand Devices [RX1 Metal Bracket]

00192029017470UR CUS W JIGS 5.0 mm Torque -4, Tip +11
00192029017463UL CUS W JIGS 5.0 mm Torque -4, Tip +11
00192029011461LR CUS W JIGS 4.5 mm Torque -11, Tip +5
00192029011454LL CUS W JIGS 4.5 mm Torque -11, Tip +5
00192029010808UR CUS W JIGS 4.5 mm Torque -4, Tip +11
00192029010792UL CUS W JIGS 4.5 mm Torque -4, Tip +11
00192029010785LO BI CW W JIGS 4.0 mm Torque -20, Tip 0
00192029010778LO BI CCW W JIGS 4.0 mm Torque -20, Tip 0
00192029010761LR CUS W JIGS 4.0 mm Torque -11, Tip +5
00192029010754LL CUS W JIGS 4.0 mm Torque -11, Tip +5
00192029010747UP BI CW W JIGS 4.0 mm Torque -7, Tip 0
00192029010730UP BI CCW W JIGS 4.0 mm Torque -7, Tip 0
00192029010723UR CEN W JIGS 4.0 mm Torque +12, Tip +5
00192029010716UL CEN W JIGS 4.0 mm Torque +12, Tip +5
00192029010709LR ANT W JIGS 3.5 mm Torque -1, Tip +2
00192029010693LL ANT W JIGS 3.5 mm Torque -1, Tip +2
00192029010662UR LAT W JIGS 3.5 mm Torque +8, Tip +9
00192029010655UL LAT W JIGS 3.5 mm Torque +8, Tip +9

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.