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) (9) System, x-ray, extraoral source, digital (MUH) (1)

Premarket Exempt

Yes No

Clear

KaVo GXS-700 Sensor Size 2 - EKAV101289780 Catalog Number : 1.012.8978

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™ intraoral sensor - EKAV101291560 Catalog Number :

Device Description : Size 1 Kit

Device Class : 2

Duns Number: 144575763

Premarket Exempt : No

Product Code : MUH

Prescription Use : No

Device Count : 1

KaVo GXS-700™ intraoral sensor - EKAV101291570 Catalog Number :

Device Description : Size 2 Kit

Device Class : 2

Duns Number: 144575763

Premarket Exempt : No

Product Code : MUH

Prescription Use : No

Device Count : 1

KaVo GXS-700™ intraoral sensor - EKAV101291580 Catalog Number :

Device Description : Size 1, Size 2 Kit

Device Class : 2

Duns Number: 144575763

Premarket Exempt : No

Product Code : MUH

Prescription Use : No

Device Count : 1

KaVo GXS-700™ intraoral sensor - EKAV101291590 Catalog Number :

Device Description : Size 1 Kit

Device Class : 2

Duns Number: 144575763

Premarket Exempt : No

Product Code : MUH

Prescription Use : No

Device Count : 1

KaVo GXS-700™ intraoral sensor - EKAV101291600 Catalog Number :

Device Description : Size 2 Kit

Device Class : 2

Duns Number: 144575763

Premarket Exempt : No

Product Code : MUH

Prescription Use : No

Device Count : 1

KaVo GXS-700™ intraoral sensor - EKAV101291610 Catalog Number :

Device Description : Size 1, Size 2 Kit

Device Class : 2

Duns Number: 144575763

Premarket Exempt : No

Product Code : MUH

Prescription Use : No

Device Count : 1

KaVo GXS-700™ intraoral sensor - EKAV101305110 Catalog Number :

Device Description : Size 1 Kit

Device Class : 2

Duns Number: 144575763

Premarket Exempt : No

Product Code : MUH

Prescription Use : No

Device Count : 1

KaVo GXS-700™ intraoral sensor - EKAV101305120 Catalog Number :

Device Description : Size 1 Kit

Device Class : 2

Duns Number: 144575763

Premarket Exempt : No

Product Code : MUH

Prescription Use : No

Device Count : 1

KaVo GXS-700™ intraoral sensor - EKAV101305130 Catalog Number :

Device Description : Size 2 Kit

Device Class : 2

Duns Number: 144575763

Premarket Exempt : No

Product Code : MUH

Prescription Use : No

Device Count : 1

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