Phonak AG

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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

Phonak - 07612847809260 Catalog Number : 050-0905-01

Device Description : Phonak Ambra microM (beige)

Device Class : 2

Duns Number: 480089517

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : No

Device Count : 1

Phonak - 07612847809277 Catalog Number : 050-0906-01

Device Description : Phonak Ambra microP (beige)

Device Class : 2

Duns Number: 480089517

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : No

Device Count : 1

Phonak - 07612847809284 Catalog Number : 050-0907-01

Device Description : Phonak Ambra SP (beige)

Device Class : 2

Duns Number: 480089517

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : No

Device Count : 1

Phonak - 07612847817517 Catalog Number : 050-0905-13

Device Description : Phonak Ambra microM (pure transparent)

Device Class : 2

Duns Number: 480089517

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : No

Device Count : 1

Phonak - 07612847817524 Catalog Number : 050-0905-33

Device Description : Phonak Ambra microM (light pink)

Device Class : 2

Duns Number: 480089517

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : No

Device Count : 1

Phonak - 07612847817531 Catalog Number : 050-0905-34

Device Description : Phonak Ambra microM (light blue)

Device Class : 2

Duns Number: 480089517

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : No

Device Count : 1

Phonak - 07612847817548 Catalog Number : 050-0905-38

Device Description : Phonak Ambra microM (purple transparent)

Device Class : 2

Duns Number: 480089517

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : No

Device Count : 1

Phonak - 07612847817555 Catalog Number : 050-0905-70

Device Description : Phonak Ambra microM (palladium/black)

Device Class : 2

Duns Number: 480089517

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : No

Device Count : 1

Phonak - 07612847817562 Catalog Number : 050-0905-B3

Device Description : Phonak Ambra microM (safari stripes)

Device Class : 2

Duns Number: 480089517

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : No

Device Count : 1

Phonak - 07612847817579 Catalog Number : 050-0905-B4

Device Description : Phonak Ambra microM (savannah beauty)

Device Class : 2

Duns Number: 480089517

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : No

Device Count : 1

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