Gendex GXS-700™ intraoral sensor 10107656

GUDID EKAV101076560

Size 1, Size 2

GENDEX CORP.

Dental digital imaging sensor, intraoral
Primary Device IDEKAV101076560
NIH Device Record Key739701b6-6cb7-4c95-98e4-6b7ccac0f012
Commercial Distribution StatusIn Commercial Distribution
Brand NameGendex GXS-700™ intraoral sensor
Version Model Number1.010.7656
Catalog Number10107656
Company DUNS144575763
Company NameGENDEX CORP.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
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

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
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
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
HIBCCEKAV101076560 [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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-24

On-Brand Devices [Gendex GXS-700™ intraoral sensor]

EKAV101081190Size 2
EKAV101081180Size 1
EKAV101078640Size 2
EKAV101078630Size 1, Size 2
EKAV101076560Size 1, Size 2
EKAV101076550Size 2
EKAV101076540Size 1Size 2
EKAV100850550Size 2
EKAV100850540Size 2
EKAV100850530Size 1
EKAV100850520Size 1
EKAV100810810Size 2, 100 Count
EKAV100762020Size 1, Size 2
EKAV100762010Size 2
EKAV100762000Size 1
EKAV082250130Size 1, Size 2
EKAV082250120Size 2
EKAV082250110Size 1
EKAV082245990Size 2
EKAV082245980Size 1

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