Rounded Rectangular Wire

GUDID 00192029016213

0.48 x 0.66mm (.019" x .026")

TP ORTHODONTICS INC

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Primary Device ID00192029016213
NIH Device Record Keycc04e2e5-10bb-4ad0-9f96-fef5e61e2679
Commercial Distribution StatusIn Commercial Distribution
Brand NameRounded Rectangular Wire
Version Model Number380-196
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
GS100192029016213 [Primary]

FDA Product Code

DZCWIRE, ORTHODONTIC

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-03-23
Device Publish Date2021-03-15

On-Brand Devices [Rounded Rectangular Wire]

00192029029596Standard Arch Form Upper
00192029029589Standard Arch Form Lower
001920290162130.48 x 0.66mm (.019" x .026")
001920290162060.46 x 0.64mm (.018" x .025")

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