GENDEX CORP.

GENDEX CORP.

Want to know more about this Organization? Request more information now!

Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

System,x-ray,extraoral source,digital (MUH) (5) CAMERA, SURGICAL AND ACCESSORIES (KQM) (2) UNIT, X-RAY, EXTRAORAL WITH TIMER (EHD) (2) UNIT, OPERATIVE DENTAL (EIA) (1)

Premarket Exempt

No Yes

Clear

Gendex GXC-300™ intraoral camera sheaths - EKAV082225320 Catalog Number : 109 0507P1

Device Description : 500 Count

Device Class :

Duns Number: 144575763

Premarket Exempt : Yes

Product Code : KQM

Prescription Use : Yes

Device Count : 500

Gendex GXC-300™ intraoral camera sheaths - EKAV082226450 Catalog Number : 112 1347G2

Device Description : 100 Count

Device Class :

Duns Number: 144575763

Premarket Exempt : Yes

Product Code : KQM

Prescription Use : Yes

Device Count : 100

Gendex GXC-300™ intraoral camera - EKAV082243310 Catalog Number : GXC300

Device Description : Digital intraoral camera

Device Class : 1

Duns Number: 144575763

Premarket Exempt : No

Product Code : EIA

Prescription Use : Yes

Device Count : 1

Gendex GXS-700™ intraoral sensor - EKAV082245980 Catalog Number : 120 0211G1

Device Description : Size 1

Device Class : 2

Duns Number: 144575763

Premarket Exempt : No

Product Code : MUH

Prescription Use : Yes

Device Count : 1

Gendex GXS-700™ intraoral sensor - EKAV082245990 Catalog Number : 120 0212G1

Device Description : Size 2

Device Class : 2

Duns Number: 144575763

Premarket Exempt : No

Product Code : MUH

Prescription Use : Yes

Device Count : 1

Gendex GXS-700™ intraoral sensor - EKAV082250110 Catalog Number : GXS70001

Device Description : Size 1

Device Class : 2

Duns Number: 144575763

Premarket Exempt : No

Product Code : MUH

Prescription Use : Yes

Device Count : 1

Gendex GXS-700™ intraoral sensor - EKAV082250120 Catalog Number : GXS70002

Device Description : Size 2

Device Class : 2

Duns Number: 144575763

Premarket Exempt : No

Product Code : MUH

Prescription Use : Yes

Device Count : 1

Gendex GXS-700™ intraoral sensor - EKAV082250130 Catalog Number : GXS70012

Device Description : Size 1, Size 2

Device Class : 2

Duns Number: 144575763

Premarket Exempt : No

Product Code : MUH

Prescription Use : Yes

Device Count : 1

Gendex eXpert DC™ intraoral x-ray system - EKAV082252120 Catalog Number : EXPERTDC55 NA

Device Description : 55 Inch Reach

Device Class : 2

Duns Number: 144575763

Premarket Exempt : No

Product Code : EHD

Prescription Use : Yes

Device Count : 1

Gendex eXpert DC™ intraoral x-ray system - EKAV082252140 Catalog Number : EXPERTDC65 NA

Device Description : 65 Inch Reach

Device Class : 2

Duns Number: 144575763

Premarket Exempt : No

Product Code : EHD

Prescription Use : Yes

Device Count : 1

Previous 1 2 3 4 5 Next