XDR CLARITY

GUDID D787XDR4P20ADSZ20

XDR CLARITY - Size-2 Digital Intraoral Sensor

CYBER MEDICAL IMAGING, INC.

Dental digital imaging sensor, intraoral
Primary Device IDD787XDR4P20ADSZ20
NIH Device Record Keyc5778edf-348e-4a6d-bcd7-46bd5aac612c
Commercial Distribution StatusIn Commercial Distribution
Brand NameXDR CLARITY
Version Model NumberXDR4P20SZ2
Company DUNS112029934
Company NameCYBER MEDICAL IMAGING, INC.
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone888-937-9729
Emailservice@xdrradiology.com
Phone888-937-9729
Emailservice@xdrradiology.com
Phone888-937-9729
Emailservice@xdrradiology.com
Phone888-937-9729
Emailservice@xdrradiology.com
Phone888-937-9729
Emailservice@xdrradiology.com
Phone888-937-9729
Emailservice@xdrradiology.com
Phone888-937-9729
Emailservice@xdrradiology.com
Phone888-937-9729
Emailservice@xdrradiology.com
Phone888-937-9729
Emailservice@xdrradiology.com
Phone888-937-9729
Emailservice@xdrradiology.com
Phone888-937-9729
Emailservice@xdrradiology.com
Phone888-937-9729
Emailservice@xdrradiology.com
Phone888-937-9729
Emailservice@xdrradiology.com
Phone888-937-9729
Emailservice@xdrradiology.com
Phone888-937-9729
Emailservice@xdrradiology.com
Phone888-937-9729
Emailservice@xdrradiology.com
Phone888-937-9729
Emailservice@xdrradiology.com

Device Dimensions

Length42.3 Millimeter
Width30.5 Millimeter
Height5.4 Millimeter
Length42.3 Millimeter
Width30.5 Millimeter
Height5.4 Millimeter
Length42.3 Millimeter
Width30.5 Millimeter
Height5.4 Millimeter
Length42.3 Millimeter
Width30.5 Millimeter
Height5.4 Millimeter
Length42.3 Millimeter
Width30.5 Millimeter
Height5.4 Millimeter
Length42.3 Millimeter
Width30.5 Millimeter
Height5.4 Millimeter
Length42.3 Millimeter
Width30.5 Millimeter
Height5.4 Millimeter
Length42.3 Millimeter
Width30.5 Millimeter
Height5.4 Millimeter
Length42.3 Millimeter
Width30.5 Millimeter
Height5.4 Millimeter
Length42.3 Millimeter
Width30.5 Millimeter
Height5.4 Millimeter
Length42.3 Millimeter
Width30.5 Millimeter
Height5.4 Millimeter
Length42.3 Millimeter
Width30.5 Millimeter
Height5.4 Millimeter
Length42.3 Millimeter
Width30.5 Millimeter
Height5.4 Millimeter
Length42.3 Millimeter
Width30.5 Millimeter
Height5.4 Millimeter
Length42.3 Millimeter
Width30.5 Millimeter
Height5.4 Millimeter
Length42.3 Millimeter
Width30.5 Millimeter
Height5.4 Millimeter
Length42.3 Millimeter
Width30.5 Millimeter
Height5.4 Millimeter

Operating and Storage Conditions

Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Same as Handling Conditions
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Same as Handling Conditions
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Same as Handling Conditions
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Same as Handling Conditions
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Same as Handling Conditions
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Same as Handling Conditions
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Same as Handling Conditions
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Same as Handling Conditions
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Same as Handling Conditions
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Same as Handling Conditions
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Same as Handling Conditions
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Same as Handling Conditions
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Same as Handling Conditions
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Same as Handling Conditions
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Same as Handling Conditions
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Same as Handling Conditions
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Same as Handling Conditions

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD787XDR4P20ADSZ20 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MUHSystem, X-Ray, Extraoral Source, Digital

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[D787XDR4P20ADSZ20]

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[D787XDR4P20ADSZ20]

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[D787XDR4P20ADSZ20]

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[D787XDR4P20ADSZ20]

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[D787XDR4P20ADSZ20]

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[D787XDR4P20ADSZ20]

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[D787XDR4P20ADSZ20]

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[D787XDR4P20ADSZ20]

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Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-05-16
Device Publish Date2023-05-08

On-Brand Devices [XDR CLARITY]

D787XDR4P20ADSZ20XDR CLARITY - Size-2 Digital Intraoral Sensor
D787XDR4P10ACSZ10XDR CLARITY - Size-1 Digital Intraoral Sensor

Trademark Results [XDR CLARITY]

Mark Image

Registration | Serial
Company
Trademark
Application Date
XDR CLARITY
XDR CLARITY
90765307 not registered Live/Pending
Cyber Medical Imaging, Inc.
2021-06-09

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