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 - 07630034393897 Catalog Number : 050-5871-P8

Device Description : T Stride P Dura 600 (charcoal)

Device Class : 2

Duns Number: 243202080

Premarket Exempt : Yes

Product Code : KLW, OSM

Prescription Use : No

Device Count : 1

UNITRON - 07630034393903 Catalog Number : 050-5871-Q9

Device Description : T Stride P Dura 600 (cinnamon)

Device Class : 2

Duns Number: 243202080

Premarket Exempt : Yes

Product Code : KLW, OSM

Prescription Use : No

Device Count : 1

UNITRON - 07630034393910 Catalog Number : 050-5871-S2

Device Description : T Stride P Dura 600 (amber suede)

Device Class : 2

Duns Number: 243202080

Premarket Exempt : Yes

Product Code : KLW, OSM

Prescription Use : No

Device Count : 1

UNITRON - 07630034393927 Catalog Number : 050-5871-S3

Device Description : T Stride P Dura 600 (espresso boost)

Device Class : 2

Duns Number: 243202080

Premarket Exempt : Yes

Product Code : KLW, OSM

Prescription Use : No

Device Count : 1

UNITRON - 07630034393934 Catalog Number : 050-5871-S5

Device Description : T Stride P Dura 600 (pewter shine)

Device Class : 2

Duns Number: 243202080

Premarket Exempt : Yes

Product Code : OSM, KLW

Prescription Use : No

Device Count : 1

UNITRON - 07630034393941 Catalog Number : 050-5871-S6

Device Description : T Stride P Dura 600 (sand storm)

Device Class : 2

Duns Number: 243202080

Premarket Exempt : Yes

Product Code : KLW, OSM

Prescription Use : No

Device Count : 1

UNITRON - 07630034393958 Catalog Number : 050-5871-S7

Device Description : T Stride P Dura 600 (teal blast)

Device Class : 2

Duns Number: 243202080

Premarket Exempt : Yes

Product Code : KLW, OSM

Prescription Use : No

Device Count : 1

UNITRON - 07630034393965 Catalog Number : 050-5881-P2

Device Description : T Moxi Now 600 (amber)

Device Class : 2

Duns Number: 243202080

Premarket Exempt : Yes

Product Code : OSM, KLW

Prescription Use : No

Device Count : 1

UNITRON - 07630034393972 Catalog Number : 050-5881-P4

Device Description : T Moxi Now 600 (espresso)

Device Class : 2

Duns Number: 243202080

Premarket Exempt : Yes

Product Code : KLW, OSM

Prescription Use : No

Device Count : 1

UNITRON - 07630034393989 Catalog Number : 050-5881-P6

Device Description : T Moxi Now 600 (platinum)

Device Class : 2

Duns Number: 243202080

Premarket Exempt : Yes

Product Code : KLW, OSM

Prescription Use : No

Device Count : 1

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