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) (10)

Premarket Exempt

Yes

Clear

UNITRON - 07613389047738 Catalog Number : 050-6060-P7

Device Description : T Max SP 500 (pewter)

Device Class : 2

Duns Number: 243202080

Premarket Exempt : Yes

Product Code : OSM, KLW

Prescription Use : No

Device Count : 1

UNITRON - 07613389047745 Catalog Number : 050-6060-P8

Device Description : T Max SP 500 (charcoal)

Device Class : 2

Duns Number: 243202080

Premarket Exempt : Yes

Product Code : OSM, KLW

Prescription Use : No

Device Count : 1

UNITRON - 07613389047783 Catalog Number : 050-6061-P2

Device Description : T Max SP 600 (amber)

Device Class : 2

Duns Number: 243202080

Premarket Exempt : Yes

Product Code : KLW, OSM

Prescription Use : No

Device Count : 1

UNITRON - 07613389047790 Catalog Number : 050-6061-P4

Device Description : T Max SP 600 (espresso)

Device Class : 2

Duns Number: 243202080

Premarket Exempt : Yes

Product Code : OSM, KLW

Prescription Use : No

Device Count : 1

UNITRON - 07613389047806 Catalog Number : 050-6061-P6

Device Description : T Max SP 600 (platinum)

Device Class : 2

Duns Number: 243202080

Premarket Exempt : Yes

Product Code : OSM, KLW

Prescription Use : No

Device Count : 1

UNITRON - 07613389048865 Catalog Number : 050-6061-P7

Device Description : T Max SP 600 (pewter)

Device Class : 2

Duns Number: 243202080

Premarket Exempt : Yes

Product Code : KLW, OSM

Prescription Use : No

Device Count : 1

UNITRON - 07613389048872 Catalog Number : 050-6061-P8

Device Description : T Max SP 600 (charcoal)

Device Class : 2

Duns Number: 243202080

Premarket Exempt : Yes

Product Code : KLW, OSM

Prescription Use : No

Device Count : 1

UNITRON - 07613389048889 Catalog Number : 050-6062-P2

Device Description : T Max SP 700 (amber)

Device Class : 2

Duns Number: 243202080

Premarket Exempt : Yes

Product Code : OSM, KLW

Prescription Use : No

Device Count : 1

UNITRON - 07613389048896 Catalog Number : 050-6062-P4

Device Description : T Max SP 700 (espresso)

Device Class : 2

Duns Number: 243202080

Premarket Exempt : Yes

Product Code : KLW, OSM

Prescription Use : No

Device Count : 1

UNITRON - 07613389048902 Catalog Number : 050-6062-P6

Device Description : T Max SP 700 (platinum)

Device Class : 2

Duns Number: 243202080

Premarket Exempt : Yes

Product Code : OSM, KLW

Prescription Use : No

Device Count : 1

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