Unitron Hearing Ltd

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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

Hearing aid, air conduction (ESD) (10)

Premarket Exempt

Yes

Clear

Unitron - 00698764246323 Catalog Number : 063-5273-01

Device Description : Next 4 CIC Omni Power

Device Class : 1

Duns Number: 201252087

Premarket Exempt : Yes

Product Code : ESD

Prescription Use : No

Device Count : 1

Unitron - 00698764246330 Catalog Number : 063-5275-01

Device Description : Next E Full Shell Dir Power

Device Class : 1

Duns Number: 201252087

Premarket Exempt : Yes

Product Code : ESD

Prescription Use : No

Device Count : 1

Unitron - 00698764246347 Catalog Number : 063-5276-01

Device Description : Next E Full Shell Dir

Device Class : 1

Duns Number: 201252087

Premarket Exempt : Yes

Product Code : ESD

Prescription Use : No

Device Count : 1

Unitron - 00698764246354 Catalog Number : 063-5277-01

Device Description : Next E Half Shell Dir

Device Class : 1

Duns Number: 201252087

Premarket Exempt : Yes

Product Code : ESD

Prescription Use : No

Device Count : 1

Unitron - 00698764246361 Catalog Number : 063-5278-01

Device Description : Next E Canal Dir

Device Class : 1

Duns Number: 201252087

Premarket Exempt : Yes

Product Code : ESD

Prescription Use : No

Device Count : 1

Unitron - 00698764246378 Catalog Number : 063-5279-01

Device Description : Next E Full Shell Omni

Device Class : 1

Duns Number: 201252087

Premarket Exempt : Yes

Product Code : ESD

Prescription Use : No

Device Count : 1

Unitron - 00698764246385 Catalog Number : 063-5280-01

Device Description : Next E Half Shell Omni

Device Class : 1

Duns Number: 201252087

Premarket Exempt : Yes

Product Code : ESD

Prescription Use : No

Device Count : 1

Unitron - 00698764246392 Catalog Number : 063-5281-01

Device Description : Next E Canal Omni

Device Class : 1

Duns Number: 201252087

Premarket Exempt : Yes

Product Code : ESD

Prescription Use : No

Device Count : 1

Unitron - 00698764246408 Catalog Number : 063-5282-01

Device Description : Next E Mini Canal Omni

Device Class : 1

Duns Number: 201252087

Premarket Exempt : Yes

Product Code : ESD

Prescription Use : No

Device Count : 1

Unitron - 00698764246415 Catalog Number : 063-5283-01

Device Description : Next E CIC Omni

Device Class : 1

Duns Number: 201252087

Premarket Exempt : Yes

Product Code : ESD

Prescription Use : No

Device Count : 1

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