Identity
- Trade Name
- Baha FDA UDI
- Generic Name
- Bone-conduction hearing implant system sound processor/vibrator FDA UDI
- Device Name
- Audio adapter Cordelle II FDA UDI
- Model / Reference
- 90067 FDA UDI
- Description
- Audio adapter Cordelle II FDA UDI
Identifiers
- Catalog Number
- 90067 FDA UDI
- Primary DI / UDI-DI
- 09321502015509 FDA UDI
- 510(k) Number
- K992872 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
No
FDA UDI
Serial Number
Yes
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
K992872 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Cochlear Bone Anchored Solutions AB
Sources (1)
- FDA UDI f4444e09-a71b-4c30-bc11-46cd677c674e 37 fields · synced May 30, 2026