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) (6) Cover, barrier, protective (MMP) (2) UNIT, OPERATIVE DENTAL (EIA) (1) UNIT, X-RAY, EXTRAORAL WITH TIMER (EHD) (1)

Premarket Exempt

No Yes

Clear

Gendex eXpert DC™ intraoral x-ray system - EKAV100625810 Catalog Number : EXPERTDC75 NA

Device Description : 75 Inch Reach

Device Class : 2

Duns Number: 144575763

Premarket Exempt : No

Product Code : EHD

Prescription Use : Yes

Device Count : 1

Gendex GXC-300™ intraoral camera - EKAV100719700 Catalog Number : 120 0209G1

Device Description : Digital intraoral cameraDigital 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 - EKAV100762000 Catalog Number : GXS70001S

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 - EKAV100762010 Catalog Number : GXS70002S

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 - EKAV100762020 Catalog Number : GXS70012S

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 - EKAV100810810 Catalog Number : 112 1434G1

Device Description : Size 2, 100 Count

Device Class :

Duns Number: 144575763

Premarket Exempt : No

Product Code : MMP

Prescription Use : Yes

Device Count : 100

Gendex GXS-700™ intraoral sensor sheaths - EKAV100810860 Catalog Number : 112 1433G1

Device Class :

Duns Number: 144575763

Premarket Exempt : No

Product Code : MMP

Prescription Use : Yes

Device Count : 100

Gendex GXS-700™ intraoral sensor - EKAV100850520 Catalog Number : GXS70012S

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 - EKAV100850530 Catalog Number : 10085053

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 - EKAV100850540 Catalog Number : 10085054

Device Description : Size 2

Device Class : 2

Duns Number: 144575763

Premarket Exempt : No

Product Code : MUH

Prescription Use : Yes

Device Count : 1

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