GENDEX CORP.

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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) (8) System, image processing, radiological (LLZ) (1) System, x-ray, extraoral source, digital (MUH) (1)

Premarket Exempt

No Yes

Clear

Gendex GXS-700™ intraoral sensor - EKAV100850550 Catalog Number : 10085055

Device Description : Size 2

Device Class : 2

Duns Number: 144575763

Premarket Exempt : No

Product Code : MUH

Prescription Use : Yes

Device Count : 1

Gendex VixWin™ imaging software - EKAV101037680 Catalog Number : VIXWINPL

Device Description : Imaging software

Device Class : 2

Duns Number: 144575763

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

Gendex GXS-700™ intraoral sensor - EKAV101076540 Catalog Number : 10107654

Device Description : Size 1Size 2

Device Class : 2

Duns Number: 144575763

Premarket Exempt : No

Product Code : MUH

Prescription Use : Yes

Device Count : 1

Gendex GXS-700™ intraoral sensor - EKAV101076550 Catalog Number : 10107655

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 - EKAV101076560 Catalog Number : 10107656

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 GXS-700™ intraoral sensor - EKAV101078630 Catalog Number : 10107863

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 GXS-700™ intraoral sensor - EKAV101078640 Catalog Number : 10107864

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 - EKAV101081180 Catalog Number : 10108118

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 - EKAV101081190 Catalog Number : 10108119

Device Description : Size 2

Device Class : 2

Duns Number: 144575763

Premarket Exempt : No

Product Code : MUH

Prescription Use : Yes

Device Count : 1

KaVo GXS-700 Sensor Size 1 - EKAV101289770 Catalog Number : 1.012.8977

Device Description : Size 1

Device Class : 2

Duns Number: 144575763

Premarket Exempt : No

Product Code : MUH

Prescription Use : Yes

Device Count : 1

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