PROVITEMP ECHPVTEMP

GUDID 03760260221221

ITENA CLINICAL

Dental composite resin
Primary Device ID03760260221221
NIH Device Record Key4f37c873-dbed-4a8b-9ecd-5e3257b8abe8
Commercial Distribution StatusIn Commercial Distribution
Brand NamePROVITEMP
Version Model NumberAutomix syringe
Catalog NumberECHPVTEMP
Company DUNS278261221
Company NameITENA CLINICAL
Device Count1
DM Exemptfalse
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
GS103760260221221 [Primary]

FDA Product Code

EMACement, Dental

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2022-11-10
Device Publish Date2017-10-31

On-Brand Devices [PROVITEMP]

03760260221221Automix syringe
03760260221030Automix syringe

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