XDR 215AC25B1

GUDID D787215AC25B11

Dental digital intraoral sensor, size 1

CYBER MEDICAL IMAGING, INC.

Dental digital imaging sensor, intraoral
Primary Device IDD787215AC25B11
NIH Device Record Keya559024c-75be-44bc-baa4-13724d828724
Commercial Distribution StatusIn Commercial Distribution
Brand NameXDR
Version Model NumberAnatomic Sensor, Size 1
Catalog Number215AC25B1
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

Phone8889379729
Emailservice@xdrRadiology.com
Phone8889379729
Emailservice@xdrRadiology.com

Device Dimensions

Height5.4 Millimeter
Length36.73 Millimeter
Width24.35 Millimeter
Height5.4 Millimeter

Operating and Storage Conditions

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
HIBCCD787215AC25B11 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MUHSystem,X-Ray,Extraoral Source,Digital

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[D787215AC25B11]

Liquid Chemical


[D787215AC25B11]

Liquid Chemical


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-12-31

On-Brand Devices [XDR]

D787XDRSW300Dental imaging software
D787XDRSW1Dental imaging software
D787215AC25B130A0Dental digital intraoral sensor, size 1
D787215AC25B11Dental digital intraoral sensor, size 1
D787213AC25B130A0Dental digital intraoral sensor, size 2
D787213AC25B11Dental digital intraoral sensor, size 2

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