Tru-Flavor

GUDID 00190707005177

MINT TRU-FLAVOR

ORTHO ORGANIZERS, INC.

Alginate dental impression material
Primary Device ID00190707005177
NIH Device Record Key102676cd-fb01-49f7-aa22-9ce52aa91b68
Commercial Distribution Discontinuation2019-01-25
Commercial Distribution StatusNot in Commercial Distribution
Brand NameTru-Flavor
Version Model Number600-004
Company DUNS062165188
Company NameORTHO ORGANIZERS, INC.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100190707005177 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ELWMATERIAL, IMPRESSION

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-01-01
Device Publish Date2016-09-24

On-Brand Devices [Tru-Flavor]

00190707005191PINA COLADA TRU-FLAVOR
00190707005184STRAWBERRY TRU-FLAVOR
00190707005177MINT TRU-FLAVOR
00190707005160CHERRY TRU-FLAVOR
00190707005153BUBBLEGUM TRU-FLAVOR
00190707005146TRU-FLAVOR KIT

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