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) (9)

Premarket Exempt

Yes

Clear

Unitron - 07613389012408 Catalog Number : 050-6044-01

Device Description : D Moxi Jump R 3 (beige)

Device Class : 2

Duns Number: 243202080

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : No

Device Count : 1

UNITRON - 07613389047592 Catalog Number : 050-6060-01

Device Description : T Max SP 500 (beige)

Device Class : 2

Duns Number: 243202080

Premarket Exempt : Yes

Product Code : KLW, OSM

Prescription Use : No

Device Count : 1

UNITRON - 07613389047608 Catalog Number : 050-6061-01

Device Description : T Max SP 600 (beige)

Device Class : 2

Duns Number: 243202080

Premarket Exempt : Yes

Product Code : OSM, KLW

Prescription Use : No

Device Count : 1

UNITRON - 07613389047615 Catalog Number : 050-6062-01

Device Description : T Max SP 700 (beige)

Device Class : 2

Duns Number: 243202080

Premarket Exempt : Yes

Product Code : KLW, OSM

Prescription Use : No

Device Count : 1

UNITRON - 07613389047622 Catalog Number : 050-6063-01

Device Description : T Max SP 800 (beige)

Device Class : 2

Duns Number: 243202080

Premarket Exempt : Yes

Product Code : KLW, OSM

Prescription Use : No

Device Count : 1

UNITRON - 07613389047639 Catalog Number : 050-6064-01

Device Description : T Max SP Pro (beige)

Device Class : 2

Duns Number: 243202080

Premarket Exempt : Yes

Product Code : KLW, OSM

Prescription Use : No

Device Count : 1

UNITRON - 07613389047646 Catalog Number : 050-6065-P7

Device Description : T Max SP FLEX:TRIAL (pewter)

Device Class : 2

Duns Number: 243202080

Premarket Exempt : Yes

Product Code : KLW, OSM

Prescription Use : No

Device Count : 1

UNITRON - 07613389047707 Catalog Number : 050-6060-P2

Device Description : T Max SP 500 (amber)

Device Class : 2

Duns Number: 243202080

Premarket Exempt : Yes

Product Code : OSM, KLW

Prescription Use : No

Device Count : 1

UNITRON - 07613389047714 Catalog Number : 050-6060-P4

Device Description : T Max SP 500 (espresso)

Device Class : 2

Duns Number: 243202080

Premarket Exempt : Yes

Product Code : OSM, KLW

Prescription Use : No

Device Count : 1

UNITRON - 07613389047721 Catalog Number : 050-6060-P6

Device Description : T Max SP 500 (beige)

Device Class : 2

Duns Number: 243202080

Premarket Exempt : Yes

Product Code : OSM, KLW

Prescription Use : No

Device Count : 1

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