Clarius Mobile Health Corp

Address:16192 Coastal Hwy,Lewes,DE,19958,US

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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, Imaging, Pulsed Doppler, Ultrasonic (IYN) (10) System, Imaging, Pulsed Echo, Ultrasonic (IYO) (10) Transducer, Ultrasonic, Diagnostic (ITX) (10)

Premarket Exempt

No Yes

Clear

Clarius Ultrasound Scanner - 07540205000014 Catalog Number : 99-02-00004; 50-02-00004

Device Class : 2

Duns Number: 202522751

Premarket Exempt : No

Product Code : IYO, ITX, IYN

Prescription Use : Yes

Device Count : 1

Clarius Ultrasound Scanner - 07540205000021 Catalog Number : 80-02-00006; 50-02-00006; AR-3501B-L7

Device Description : ARTHREX Linear Transducer

Device Class : 2

Duns Number: 202522751

Premarket Exempt : No

Product Code : IYN, ITX, IYO

Prescription Use : Yes

Device Count : 1

Clarius Ultrasound Scanner - 07540205000038 Catalog Number : 80-02-00003; 50-02-00003; AR-3501B-C3

Device Description : ARTHREX Curvilinear Scanner

Device Class : 2

Duns Number: 202522751

Premarket Exempt : No

Product Code : IYO, ITX, IYN

Prescription Use : Yes

Device Count : 1

Synergy MSK Ultrasound Scanner - 07540205000045 Catalog Number : 80-02-00005; 50-02-00005

Device Class : 2

Duns Number: 202522751

Premarket Exempt : No

Product Code : ITX, IYN, IYO

Prescription Use : Yes

Device Count : 1

Clarius Ultrasound Scanner - 07540205000168 Catalog Number : 99-02-00001

Device Class : 2

Duns Number: 202522751

Premarket Exempt : No

Product Code : ITX, IYN, IYO

Prescription Use : Yes

Device Count : 1

Clarius Ultrasound Scanner - 07540205000175 Catalog Number : 80-02-00002; AR-3500-01C

Device Description : ARTHREX Charger

Device Class : 2

Duns Number: 202522751

Premarket Exempt : No

Product Code : ITX, IYN, IYO

Prescription Use : Yes

Device Count : 1

Clarius Ultrasound Scanner - 07540205000199 Catalog Number : 80-02-00009; 50-02-00003

Device Description : ARTHREX Synergy Curvilinear Scanner

Device Class : 2

Duns Number: 202522751

Premarket Exempt : No

Product Code : IYN, IYO, ITX

Prescription Use : Yes

Device Count : 1

Synergy MSK Ultrasound Scanner - 07540205000205 Catalog Number : 80-02-00010; 50-02-00005

Device Description : Clarius brand C7 Premium scanner

Device Class : 2

Duns Number: 202522751

Premarket Exempt : No

Product Code : IYO, IYN, ITX

Prescription Use : Yes

Device Count : 1

Clarius Ultrasound Scanner - 07540205000212 Catalog Number : 80-02-00011; 50-02-00006

Device Class : 2

Duns Number: 202522751

Premarket Exempt : No

Product Code : IYN, IYO, ITX

Prescription Use : Yes

Device Count : 1

Clarius Ultrasound Scanner - 07540205000298 Catalog Number : 80-02-00012; 50-02-00003

Device Class : 2

Duns Number: 202522751

Premarket Exempt : No

Product Code : IYN, IYO, ITX

Prescription Use : Yes

Device Count : 1

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