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Baha

FDA UDI

Class II (US FDA UDI)

by Cochlear Bone Anchored Solutions AB

Identity

Trade Name
Baha FDA UDI
Generic Name
Valve-non-specific transcatheter heart valve bioprosthesis FDA UDI
Device Name
Abutment cleaning brush FDA UDI
Model / Reference
91040 FDA UDI
Description
Abutment cleaning brush FDA UDI

Identifiers

Catalog Number
91040 FDA UDI
Primary DI / UDI-DI
09321502020800 FDA UDI
510(k) Number
K090720 FDA UDI
FDA Product Code
LXB FDA UDI
GMDN Term
Valve-non-specific transcatheter heart valve bioprosthesis FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
874.3302 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Valve-non-specific transcatheter heart valve bioprosthesis

Baha by Cochlear Bone Anchored Solutions AB — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Valve-non-specific transcatheter heart valve bioprosthesis.

Cleared under the same submission

K090720 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Cochlear Bone Anchored Solutions AB

Sources (1)

  • FDA UDI 2a9b4afe-5a29-43ad-bdaf-ed207c4365f1 36 fields · synced May 30, 2026