Vario DG

GUDID E31562802700

Intraoral X-ray unit (70 kV, 3.5 mA), sensor not included

FONA SRL

Stationary intraoral dental x-ray system, digital
Primary Device IDE31562802700
NIH Device Record Keyfed679b2-e3ab-4d47-bda2-57db339c7636
Commercial Distribution StatusIn Commercial Distribution
Brand NameVario DG
Version Model Number6280270
Company DUNS514320345
Company NameFONA SRL
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 Batchfalse
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

Phone+390245712171
Emailinfo@fonadental.it
Phone+390245712171
Emailinfo@fonadental.it
Phone+390245712171
Emailinfo@fonadental.it
Phone+390245712171
Emailinfo@fonadental.it
Phone+390245712171
Emailinfo@fonadental.it
Phone+390245712171
Emailinfo@fonadental.it
Phone+390245712171
Emailinfo@fonadental.it
Phone+390245712171
Emailinfo@fonadental.it
Phone+390245712171
Emailinfo@fonadental.it
Phone+390245712171
Emailinfo@fonadental.it
Phone+390245712171
Emailinfo@fonadental.it
Phone+390245712171
Emailinfo@fonadental.it
Phone+390245712171
Emailinfo@fonadental.it
Phone+390245712171
Emailinfo@fonadental.it
Phone+390245712171
Emailinfo@fonadental.it
Phone+390245712171
Emailinfo@fonadental.it
Phone+390245712171
Emailinfo@fonadental.it
Phone+390245712171
Emailinfo@fonadental.it

Operating and Storage Conditions

Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0.7 KiloPascal and 1.06 KiloPascal
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0.7 KiloPascal and 1.06 KiloPascal
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0.7 KiloPascal and 1.06 KiloPascal
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0.7 KiloPascal and 1.06 KiloPascal
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0.7 KiloPascal and 1.06 KiloPascal
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0.7 KiloPascal and 1.06 KiloPascal
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0.7 KiloPascal and 1.06 KiloPascal
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0.7 KiloPascal and 1.06 KiloPascal
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0.7 KiloPascal and 1.06 KiloPascal
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0.7 KiloPascal and 1.06 KiloPascal
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0.7 KiloPascal and 1.06 KiloPascal
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0.7 KiloPascal and 1.06 KiloPascal
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0.7 KiloPascal and 1.06 KiloPascal
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0.7 KiloPascal and 1.06 KiloPascal
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0.7 KiloPascal and 1.06 KiloPascal
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0.7 KiloPascal and 1.06 KiloPascal
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0.7 KiloPascal and 1.06 KiloPascal
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCE31562802700 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EHDUnit, X-Ray, Extraoral With Timer

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 Date2016-09-10

Devices Manufactured by FONA SRL

E3158468260320 - FONA ART Plus2023-06-20
E3158468463121 - FONA ART Plus C2023-06-20
E3158468463221 - FONA ART Plus C2023-06-20
E3159319001700 - FONA XDC2022-09-14
E3158468600000 - Stellaris 3D2022-05-09
E3158468600002 - Stellaris 3D Ceph2022-05-09
E3158468600007 - Stellaris 2D2022-05-09
E3158468600008 - Stellaris 2D Ceph2022-05-09

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