Gendex eXpert DC™ intraoral x-ray system EXPERTDC55 NA

GUDID EKAV082252120

55 Inch Reach

GENDEX CORP.

Stationary intraoral dental x-ray system, digital
Primary Device IDEKAV082252120
NIH Device Record Key519fc68c-4eb2-426d-8668-0d51d28a53e0
Commercial Distribution StatusIn Commercial Distribution
Brand NameGendex eXpert DC™ intraoral x-ray system
Version Model Number0.822.5212
Catalog NumberEXPERTDC55 NA
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 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
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

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCEKAV082252120 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EHDUNIT, X-RAY, EXTRAORAL WITH TIMER

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-10-29
Device Publish Date2016-09-27

On-Brand Devices [Gendex eXpert DC™ intraoral x-ray system]

EKAV10062581075 Inch Reach
EKAV08225214065 Inch Reach
EKAV08225212055 Inch Reach

Trademark Results [Gendex eXpert DC]

Mark Image

Registration | Serial
Company
Trademark
Application Date
GENDEX EXPERT DC
GENDEX EXPERT DC
78853112 3399919 Dead/Cancelled
DENTAL IMAGING TECHNOLOGIES CORPORATION
2006-04-04

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.