Gendex GXC-300™ intraoral camera GXC300

GUDID EKAV082243310

Digital intraoral camera

GENDEX CORP.

Multi-purpose digital medical camera
Primary Device IDEKAV082243310
NIH Device Record Keyb373d4bf-9daf-4897-95dd-0c13790d0340
Commercial Distribution StatusIn Commercial Distribution
Brand NameGendex GXC-300™ intraoral camera
Version Model Number0.822.4331
Catalog NumberGXC300
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
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 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCEKAV082243310 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EIAUNIT, OPERATIVE DENTAL

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 GXC-300™ intraoral camera]

EKAV100719700Digital intraoral cameraDigital intraoral camera
EKAV082243310Digital intraoral camera

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