KaVo GXS-700 Sensor Size 2 1.012.8978

GUDID EKAV101289780

Size 2

GENDEX CORP.

Dental digital imaging sensor, intraoral
Primary Device IDEKAV101289780
NIH Device Record Key0fd641f2-e723-4b4e-95d0-59a4082ac1bf
Commercial Distribution StatusIn Commercial Distribution
Brand NameKaVo GXS-700 Sensor Size 2
Version Model Number1.012.8978
Catalog Number1.012.8978
Company DUNS144575763
Company NameGENDEX CORP.
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 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+18003238029
Emailinfo@gendex.com
Phone+18003238029
Emailinfo@gendex.com
Phone+18003238029
Emailinfo@gendex.com
Phone+18003238029
Emailinfo@gendex.com
Phone+18003238029
Emailinfo@gendex.com
Phone+18003238029
Emailinfo@gendex.com
Phone+18003238029
Emailinfo@gendex.com
Phone+18003238029
Emailinfo@gendex.com
Phone+18003238029
Emailinfo@gendex.com
Phone+18003238029
Emailinfo@gendex.com
Phone+18003238029
Emailinfo@gendex.com
Phone+18003238029
Emailinfo@gendex.com
Phone+18003238029
Emailinfo@gendex.com
Phone+18003238029
Emailinfo@gendex.com
Phone+18003238029
Emailinfo@gendex.com
Phone+18003238029
Emailinfo@gendex.com

Operating and Storage Conditions

Handling Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCEKAV101289780 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MUHSystem, x-ray, extraoral source, digital

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-11-08
Device Publish Date2018-10-08

Devices Manufactured by GENDEX CORP.

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EKAV101291580 - KaVo GXS-700™ intraoral sensor2022-01-31 Size 1, Size 2 Kit
EKAV101291590 - KaVo GXS-700™ intraoral sensor2022-01-31 Size 1 Kit
EKAV101291600 - KaVo GXS-700™ intraoral sensor2022-01-31 Size 2 Kit
EKAV101291610 - KaVo GXS-700™ intraoral sensor2022-01-31 Size 1, Size 2 Kit
EKAV101305110 - KaVo GXS-700™ intraoral sensor2022-01-31 Size 1 Kit
EKAV101305120 - KaVo GXS-700™ intraoral sensor2022-01-31 Size 1 Kit

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