MAGNA 4.0 CR1079ABC

GUDID D813CR1079ABC0

AVID BLUE CURE CURING LIGHT

DEN-MAT HOLDINGS, LLC

Dental/surgical polymerization lamp Dental/surgical polymerization lamp
Primary Device IDD813CR1079ABC0
NIH Device Record Keyff52566f-cacd-499a-9b8e-ce6104422637
Commercial Distribution StatusIn Commercial Distribution
Brand NameMAGNA 4.0
Version Model NumberCR1079ABC
Catalog NumberCR1079ABC
Company DUNS809857704
Company NameDEN-MAT HOLDINGS, LLC
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 Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-4336628
Emailinfo@denmat.com
Phone1-800-4336628
Emailinfo@denmat.com

Operating and Storage Conditions

Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween -4 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD813CR1079ABC0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EBZActivator, Ultraviolet, For Polymerization

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-09-28

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