Straight Edge Metal Bracket

GUDID 00192029022344

UL CUS NO HK W JIGS 4.5mm Torque -2, Tip +11, Rot -4 0.56mm (0.022")

TP ORTHODONTICS INC

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Primary Device ID00192029022344
NIH Device Record Key57f289f6-da02-492d-af84-39a3e777733d
Commercial Distribution StatusIn Commercial Distribution
Brand NameStraight Edge Metal Bracket
Version Model Number292-097
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
GS100192029022344 [Primary]
GS100192029022344 [Primary]
GS100192029022344 [Primary]
GS100192029022344 [Primary]
GS100192029022344 [Primary]
GS100192029022344 [Primary]
GS100192029022344 [Primary]
GS100192029022344 [Primary]
GS100192029022344 [Primary]
GS100192029022344 [Primary]
GS100192029022344 [Primary]
GS100192029022344 [Primary]
GS100192029022344 [Primary]
GS100192029022344 [Primary]
GS100192029022344 [Primary]
GS100192029022344 [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 [Straight Edge Metal Bracket]

00192029022771UP/LO W/ TE CUS SPECIAL JIGS
00192029022764UR BI W JIGS 4.5mm Torque -7, Tip 0, Rot +2
00192029022757UL BI W JIGS 4.5mm Torque -7, Tip 0, Rot +2
00192029022740UR BI W JIGS 4mm Torque -7, Tip 0, Rot +2
00192029022733UL BI W JIGS 4mm Torque -7, Tip 0, Rot +2
00192029022726UR BI W JIGS 3.5mm Torque -7, Tip 0, Rot +2
00192029022719UL BI W JIGS 3.5mm Torque -7, Tip 0, Rot +2
00192029022702UR BI Torque -7, Tip 0, Rot +2
00192029022696UL BI Torque -7, Tip 0, Rot +2
00192029022689UR BI W JIGS 4mm Torque -7, Tip 0, Rot +2
00192029022672UL BI W JIGS 4mm Torque -7, Tip 0, Rot +2
00192029022665UR BI W JIGS 3.5mm Torque -7, Tip 0, Rot +2
00192029022658UL BI W JIGS 3.5mm Torque -7, Tip 0, Rot +2
00192029022641UR BI Torque -7, Tip 0, Rot +2
00192029022634UL BI Torque -7, Tip 0, Rot +2
00192029022627UR 2nd BI Torque -7, Tip +2
00192029022610UR 1st BI Torque -7, Tip +2
00192029022603UL 2nd BI Torque -7, Tip +2
00192029022597UL 1st BI Torque -7, Tip +2
00192029022580LO UNIV ANT W JIGS 3.5mm Torque -6, Tip 0
00192029022573LO UNIV ANT Torque -6, Tip 0
00192029022566LO UNIV ANT W JIGS 3.5mm Torque -6, Tip 0
00192029022559LO UNIV ANT Torque -6, Tip 0
00192029022542LO UNIV ANT Torque -6, Tip 0
00192029022535LR 2nd BI Torque -22, Tip +2
00192029022528LL 2nd BI Torque -22, Tip +2
00192029022511LR 2nd BI W JIGS 4.5mm Torque -22, Tip +1, Rot +4 Gingival offset
00192029022504LL 2nd BI W JIGS 4.5mm Torque -22, Tip +1, Rot +4 Gingival offset
00192029022498LR 2nd BI W JIGS 4.5mm Torque -22, Tip +1, Rot +4
00192029022481LL 2nd BI W JIGS 4.5mm Torque -22, Tip +1, Rot +4
00192029022474LR 2nd BI W JIGS 4mm Torque -22, Tip +1, Rot +4
00192029022467LL 2nd BI W JIGS 4mm Torque -22, Tip +1, Rot +4
00192029022450LR 2nd BI Torque -22, Tip +1, Rot +4
00192029022443LL 2nd BI Torque -22, Tip +1, Rot +4
00192029022436LR 2nd BI W JIGS 4mm Torque -22, Tip +1, Rot +4
00192029022429LL 2nd BI W JIGS 4mm Torque -22, Tip +1, Rot +4
00192029022412LR 2nd BI Torque -22, Tip +1, Rot +4
00192029022405LL 2nd BI Torque -22, Tip +1, Rot +4
00192029022399UR CUS W/DISTAL HK Torque -2, Tip +11, Rot -4
00192029022382UL CUS W/DISTAL HK Torque -2, Tip +11, Rot -4
00192029022375UR CUS NO HK W JIGS 4.5mm Torque -2, Tip +11, Rot -4
00192029022368UR CUS NO HK W JIGS 4.5mm Torque -2, Tip +11, Rot -4
00192029022351UL CUS NO HK W JIGS 4.5mm Torque -2, Tip +11, Rot -4
00192029022344UL CUS NO HK W JIGS 4.5mm Torque -2, Tip +11, Rot -4
00192029022337UR CUS NO HK Torque -2, Tip +11, Rot -4
00192029022320UL CUS NO HK Torque -2, Tip +11, Rot -4
00192029022313UR CUS NO HK W JIGS 4.5mm Torque -2, Tip +11, Rot -4
00192029022306UR CUS NO HK W JIGS 4.5mm Torque -2, Tip +11, Rot -4
00192029022290UL CUS NO HK W JIGS 4.5mm Torque -2, Tip +11, Rot -4
00192029022283UL CUS NO HK W JIGS 4.5mm Torque -2, Tip +11, Rot -4

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