FIESTA PINK Tru-Force Latex Elastics

GUDID 00192029037195

Bulk Pack Plain Latex

TP ORTHODONTICS INC

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Primary Device ID00192029037195
NIH Device Record Key2dc32a8e-d2c3-4dc0-9ff2-c8216229af11
Commercial Distribution StatusIn Commercial Distribution
Brand NameFIESTA PINK Tru-Force Latex Elastics
Version Model Number360-024
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 Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100192029037195 [Primary]

FDA Product Code

ECIBAND, ELASTIC, 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 [FIESTA PINK Tru-Force Latex Elastics]

00192029039618Carton Plain Latex
00192029037348Master Pouch 20 Cases
00192029037195Bulk Pack

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