KaVo GXS-700 Sensor Size 1 1.012.8977

GUDID EKAV101289770

Size 1

GENDEX CORP.

Dental digital imaging sensor, intraoral
Primary Device IDEKAV101289770
NIH Device Record Key3978d050-7bf1-4db2-ab24-97b05849be74
Commercial Distribution StatusIn Commercial Distribution
Brand NameKaVo GXS-700 Sensor Size 1
Version Model Number1.012.8977
Catalog Number1.012.8977
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
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

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCEKAV101289770 [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.

EKAV101291560 - KaVo GXS-700™ intraoral sensor2022-01-31 Size 1 Kit
EKAV101291570 - KaVo GXS-700™ intraoral sensor2022-01-31 Size 2 Kit
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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