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) PROSTHESIS, NOSE, INTERNAL (FZE) (4)

Premarket Exempt

Yes No

Clear

Baha - 09321502014304 Catalog Number : 90448

Device Description : Gold bar Ø2 x 100 mm

Device Class : 2

Duns Number: 559784736

Premarket Exempt : No

Product Code : LXB

Prescription Use : Yes

Device Count : 1

Baha - 09321502014311 Catalog Number : 90446

Device Description : Gold bar Ø2 x 50 mm

Device Class : 2

Duns Number: 559784736

Premarket Exempt : No

Product Code : LXB

Prescription Use : Yes

Device Count : 1

Baha - 09321502014328 Catalog Number : 90440

Device Description : Fixture ST 4mm

Device Class : 2

Duns Number: 559784736

Premarket Exempt : No

Product Code : LXB

Prescription Use : Yes

Device Count : 1

Baha - 09321502014335 Catalog Number : 90438

Device Description : Fixture ST 3mm

Device Class : 2

Duns Number: 559784736

Premarket Exempt : No

Product Code : LXB

Prescription Use : Yes

Device Count : 1

Baha - 09321502014342 Catalog Number : 90436

Device Description : Healing abutment 7mm Unigrip

Device Class : 2

Duns Number: 559784736

Premarket Exempt : No

Product Code : LXB

Prescription Use : Yes

Device Count : 1

Baha - 09321502014359 Catalog Number : 90434

Device Description : Flange fixture ST 4mm w. BAHA abutment

Device Class : 2

Duns Number: 559784736

Premarket Exempt : No

Product Code : LXB

Prescription Use : Yes

Device Count : 1

Baha - 09321502014366 Catalog Number : 90429

Device Description : Console abutment 110° Unigrip

Device Class : 2

Duns Number: 559784736

Premarket Exempt : No

Product Code : FZE

Prescription Use : Yes

Device Count : 1

Baha - 09321502014373 Catalog Number : 90428

Device Description : Console abutment 90° Unigrip

Device Class : 2

Duns Number: 559784736

Premarket Exempt : No

Product Code : FZE

Prescription Use : Yes

Device Count : 1

Baha - 09321502014380 Catalog Number : 90427

Device Description : Console abutment 60° Unigrip

Device Class : 2

Duns Number: 559784736

Premarket Exempt : No

Product Code : FZE

Prescription Use : Yes

Device Count : 1

Baha - 09321502014397 Catalog Number : 90426

Device Description : Console abutment 30° Unigrip

Device Class : 2

Duns Number: 559784736

Premarket Exempt : No

Product Code : FZE

Prescription Use : Yes

Device Count : 1

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