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) Masker, tinnitus (KLW) (8)

Premarket Exempt

Yes

Clear

UNITRON - 07630034393996 Catalog Number : 050-5881-P7

Device Description : T Moxi Now 600 (pewter)

Device Class : 2

Duns Number: 243202080

Premarket Exempt : Yes

Product Code : KLW, OSM

Prescription Use : No

Device Count : 1

UNITRON - 07630034394009 Catalog Number : 050-5881-P8

Device Description : T Moxi Now 600 (charcoal)

Device Class : 2

Duns Number: 243202080

Premarket Exempt : Yes

Product Code : KLW, OSM

Prescription Use : No

Device Count : 1

UNITRON - 07630034394016 Catalog Number : 050-5881-Q9

Device Description : T Moxi Now 600 (cinnamon)

Device Class : 2

Duns Number: 243202080

Premarket Exempt : Yes

Product Code : KLW, OSM

Prescription Use : No

Device Count : 1

UNITRON - 07630034394023 Catalog Number : 050-5881-S2

Device Description : T Moxi Now 600 (amber suede)

Device Class : 2

Duns Number: 243202080

Premarket Exempt : Yes

Product Code : KLW, OSM

Prescription Use : No

Device Count : 1

UNITRON - 07630034394030 Catalog Number : 050-5881-S3

Device Description : T Moxi Now 600 (espresso boost)

Device Class : 2

Duns Number: 243202080

Premarket Exempt : Yes

Product Code : KLW, OSM

Prescription Use : No

Device Count : 1

UNITRON - 07630034394047 Catalog Number : 050-5881-S5

Device Description : T Moxi Now 600 (pewter shine)

Device Class : 2

Duns Number: 243202080

Premarket Exempt : Yes

Product Code : KLW, OSM

Prescription Use : No

Device Count : 1

UNITRON - 07630034394054 Catalog Number : 050-5881-S6

Device Description : T Moxi Now 600 (sand storm)

Device Class : 2

Duns Number: 243202080

Premarket Exempt : Yes

Product Code : KLW, OSM

Prescription Use : No

Device Count : 1

UNITRON - 07630034394061 Catalog Number : 050-5881-S7

Device Description : T Moxi Now 600 (teal blast)

Device Class : 2

Duns Number: 243202080

Premarket Exempt : Yes

Product Code : KLW, OSM

Prescription Use : No

Device Count : 1

Unitron - 07630034394641 Catalog Number : 050-5771-0144

Device Description : Vista T 610 R 312 (beige)

Device Class : 2

Duns Number: 243202080

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : No

Device Count : 1

Unitron - 07630034394658 Catalog Number : 050-5781-0144

Device Description : Vista T 610 P 13 (beige)

Device Class : 2

Duns Number: 243202080

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : No

Device Count : 1

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