TEMREX POWDER

GUDID 00850015110139

POWDER FOR MIXING WITH DENTAL CEMENT LIQUID

TEMREX CORPORATION

Zinc oxide eugenol dental cement
Primary Device ID00850015110139
NIH Device Record Key8d4affc0-d393-4d0d-881c-8504f9ead739
Commercial Distribution StatusIn Commercial Distribution
Brand NameTEMREX POWDER
Version Model Number332 Yellow/Gray 25gm.
Company DUNS012072823
Company NameTEMREX CORPORATION
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
GS100850015110139 [Primary]

FDA Product Code

EMACement, Dental

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-02-21
Device Publish Date2020-02-13

On-Brand Devices [TEMREX POWDER]

00850015110184POWDER FOR MIXING WITH DENTAL CEMENT LIQUID
00850015110177POWDER FOR MIXING WITH DENTAL CEMENT LIQUID
00850015110160POWDER FOR MIXING WITH DENTAL CEMENT LIQUID
00850015110153POWDER FOR MIXING WITH DENTAL CEMENT LIQUID
00850015110146POWDER FOR MIXING WITH DENTAL CEMENT LIQUID
00850015110139POWDER FOR MIXING WITH DENTAL CEMENT LIQUID
00850015110122POWDER FOR MIXING WITH DENTAL CEMENT LIQUID
00850015110030POWDER FOR MIXING WITH CEMENT LIQUID

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