Cochlear Bone Anchored Solutions AB

Address:Konstruktionsvagen 14,Molnlycke Vastra Gotaland,SE

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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, bone conduction (LXB) (6) Instrument, Ent Manual Surgical (LRC) (2) PROSTHESIS, NOSE, INTERNAL (FZE) (2)

Premarket Exempt

Yes No

Clear

Guide pin 20 mm - 09321502016018 Catalog Number : 90796

Device Description : Laboratory component for prior generation Vistafix

Device Class : 2

Duns Number: 559784736

Premarket Exempt : No

Product Code : FZE

Prescription Use : Yes

Device Count : 1

Baha - 09321502016032 Catalog Number : 90627

Device Description : Audio cord black 75 cm

Device Class : 2

Duns Number: 559784736

Premarket Exempt : No

Product Code : LXB

Prescription Use : Yes

Device Count : 1

Abutment replica - 09321502016230 Catalog Number : 90374

Device Description : Laboratory component for prior generation Vistafix

Device Class : 2

Duns Number: 559784736

Premarket Exempt : No

Product Code : FZE

Prescription Use : Yes

Device Count : 1

Baha - 09321502016292 Catalog Number : 90784

Device Description : Case anthracite with insert Divino

Device Class : 2

Duns Number: 559784736

Premarket Exempt : No

Product Code : LXB

Prescription Use : No

Device Count : 1

Raspatorium - 09321502016490 Catalog Number : 90944

Device Description : N/A

Device Class : 1

Duns Number: 559784736

Premarket Exempt : Yes

Product Code : LRC

Prescription Use : Yes

Device Count : 1

Dissector - 09321502016506 Catalog Number : 90943

Device Description : N/A

Device Class : 1

Duns Number: 559784736

Premarket Exempt : Yes

Product Code : LRC

Prescription Use : Yes

Device Count : 1

Baha - 09321502016513 Catalog Number : 90381

Device Description : Machine Screwdriver 25mm UniGrip

Device Class : 2

Duns Number: 559784736

Premarket Exempt : No

Product Code : LXB

Prescription Use : Yes

Device Count : 1

Baha - 09321502016551 Catalog Number : 91180

Device Description : Cochlear Baha Audio adapter Short Cable

Device Class : 2

Duns Number: 559784736

Premarket Exempt : No

Product Code : LXB

Prescription Use : Yes

Device Count : 1

Baha - 09321502016568 Catalog Number : 91181

Device Description : Cochlear Baha Telecoil

Device Class : 2

Duns Number: 559784736

Premarket Exempt : No

Product Code : LXB

Prescription Use : Yes

Device Count : 1

Baha - 09321502016674 Catalog Number : 91868

Device Description : Cochlear Baha Audio adapter Long Cable

Device Class : 2

Duns Number: 559784736

Premarket Exempt : No

Product Code : LXB

Prescription Use : Yes

Device Count : 1

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