XDR 213AC25B130A

GUDID D787213AC25B130A0

Dental digital intraoral sensor, size 2

CYBER MEDICAL IMAGING, INC.

Dental digital imaging sensor, intraoral
Primary Device IDD787213AC25B130A0
NIH Device Record Key08cb9a36-9e58-42fd-964d-0d360f185779
Commercial Distribution StatusIn Commercial Distribution
Brand NameXDR
Version Model NumberAnatomic Sensor, Size 2
Catalog Number213AC25B130A
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

Height6.6 Millimeter
Width30.49 Millimeter
Length42.8 Millimeter
Height6.6 Millimeter

Operating and Storage Conditions

Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Same as Handling Conditions
Handling Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
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
HIBCCD787213AC25B130A0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MUHSystem,X-Ray,Extraoral Source,Digital

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[D787213AC25B130A0]

Liquid Chemical


[D787213AC25B130A0]

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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