ARIBEX, INC.

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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, mobile (IZL) (5) UNIT, X-RAY, EXTRAORAL WITH TIMER (EHD) (5)

Premarket Exempt

Clear

NOMAD Pro 2™ - EKAV085000280 Catalog Number : FP 0192

Device Description : Handheld X-ray, Black

Device Class : 2

Duns Number: 169065526

Premarket Exempt : No

Product Code : EHD

Prescription Use : Yes

Device Count : 1

NOMAD MD™ handheld X-ray system - EKAV085000300 Catalog Number : FP 0201

Device Description : Handheld X-ray

Device Class : 2

Duns Number: 169065526

Premarket Exempt : No

Product Code : IZL

Prescription Use : Yes

Device Count : 1

NOMAD™ handheld X-ray system - EKAV085000420 Catalog Number : AP 0001 RFB

Device Description : Handheld X-ray

Device Class : 2

Duns Number: 169065526

Premarket Exempt : No

Product Code : EHD

Prescription Use : Yes

Device Count : 1

NOMAD MD™ handheld X-ray system - EKAV085001120 Catalog Number : AP 0200

Device Description : Handheld X-ray

Device Class : 2

Duns Number: 169065526

Premarket Exempt : No

Product Code : IZL

Prescription Use : Yes

Device Count : 1

NOMAD MD™ handheld X-ray system - EKAV085004700 Catalog Number : FP 0204

Device Description : Handheld x-ray

Device Class : 2

Duns Number: 169065526

Premarket Exempt : No

Product Code : IZL

Prescription Use : Yes

Device Count : 1

NOMAD MD™ handheld X-ray system - EKAV085004710 Catalog Number : FP 0202

Device Description : Handheld x-ray

Device Class : 2

Duns Number: 169065526

Premarket Exempt : No

Product Code : IZL

Prescription Use : Yes

Device Count : 1

NOMAD MD™ handheld X-ray system - EKAV101152780 Catalog Number : FP 0203

Device Description : Handheld x-ray

Device Class : 2

Duns Number: 169065526

Premarket Exempt : No

Product Code : IZL

Prescription Use : Yes

Device Count : 1

Packaged System, Kavo Nomad Pro2, US - EKAV101320400 Catalog Number : 1.013.2040

Device Description : This is a medical device.

Device Class : 2

Duns Number: 169065526

Premarket Exempt : No

Product Code : EHD

Prescription Use : Yes

Device Count : 1

Packaged System, Kavo Nomad Pro2, GBL - EKAV101320410 Catalog Number : 1.013.2041

Device Description : this is a medical device

Device Class : 2

Duns Number: 169065526

Premarket Exempt : No

Product Code : EHD

Prescription Use : Yes

Device Count : 1

Packaged System, KaVo Nomad Pro2, CA - EKAV101377890 Catalog Number : 1.013.7789

Device Description : This is a medical device.

Device Class : 2

Duns Number: 169065526

Premarket Exempt : No

Product Code : EHD

Prescription Use : Yes

Device Count : 1

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