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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
Bone-conduction hearing implant system sound processor/vibrator FDA UDI
Device Name
Baha BP110 Power tamper-proof battery doors Sky Blue FDA UDI
Model / Reference
93087 FDA UDI
Description
Baha BP110 Power tamper-proof battery doors Sky Blue FDA UDI

Identifiers

Catalog Number
93087 FDA UDI
Primary DI / UDI-DI
09321502040228 FDA UDI
510(k) Number
K110996 FDA UDI
FDA Product Code
LXB FDA UDI
GMDN Term
Bone-conduction hearing implant system sound processor/vibrator FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
874.3302 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

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

Cleared under the same submission

K110996 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 a3fd03b7-42bb-4a8c-947f-2c919751ac4d 37 fields · synced Jun 1, 2026