TEAL Tru-Force Latex Elastics

GUDID 00192029037331

Master Pouch 20 Cases Plain Latex

TP ORTHODONTICS INC

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Primary Device ID00192029037331
NIH Device Record Key64db8688-ad92-4d07-a67f-2e227eb48ca9
Commercial Distribution StatusIn Commercial Distribution
Brand NameTEAL Tru-Force Latex Elastics
Version Model Number362-023
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
GS100192029037331 [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 [TEAL Tru-Force Latex Elastics]

00192029039601Carton Plain Latex
00192029037331Master Pouch 20 Cases
00192029037188Bulk Pack

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