Unitron Hearing Division

Unitron Hearing Division

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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 with wireless technology (OSM) (10)

Premarket Exempt

Yes

Clear

UNITRON - 00698764302210 Catalog Number : 076-5001-0011

Device Description : uDirect, Incl. US Power Supply

Device Class : 2

Duns Number: 243202080

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : No

Device Count : 1

UNITRON - 00698764410984 Catalog Number : 076-5015

Device Description : Unitron Remote RCV1 '-Swiss Made

Device Class : 2

Duns Number: 243202080

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : No

Device Count : 1

UNITRON - 00698764443357 Catalog Number : 076-5018

Device Description : uDirect 2 (Swiss Made)

Device Class : 2

Duns Number: 243202080

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : No

Device Count : 1

UNITRON - 00698764515658 Catalog Number : 054-5781

Device Description : IIC Remote Control

Device Class : 2

Duns Number: 243202080

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : No

Device Count : 1

UNITRON - 00698764589161 Catalog Number : 076-5022-T820

Device Description : uTV 3 w/ Univ. Power Supply

Device Class : 2

Duns Number: 243202080

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : No

Device Count : 1

UNITRON - 00698764594042 Catalog Number : 076-5037-T809070

Device Description : uStream packaged (Swiss Made)

Device Class : 2

Duns Number: 243202080

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : No

Device Count : 1

UNITRON - 00698764597463 Catalog Number : 076-5033-T809070

Device Description : uDirect 3 BTE Box (Swiss made)

Device Class : 2

Duns Number: 243202080

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : No

Device Count : 1

UNITRON - 00698764601191 Catalog Number : 076-5040-T8

Device Description : uStream for Bundle (cashmere silver)

Device Class : 2

Duns Number: 243202080

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : No

Device Count : 1

UNITRON - 07612904187966 Catalog Number : 054-3028

Device Description : Smart Control New Logo

Device Class : 2

Duns Number: 243202080

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : No

Device Count : 1

Unitron - 07613389012385 Catalog Number : 050-6030-01

Device Description : D Moxi Fit 3 (beige)

Device Class : 2

Duns Number: 243202080

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : No

Device Count : 1

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