Identity
- Trade Name
- Baha SoundArc Extra Large FDA UDI
- Generic Name
- Bone-conduction hearing implant system sound processor/vibrator FDA UDI
- Device Name
- N/A FDA UDI
- Model / Reference
- P807178 FDA UDI
- Description
- N/A FDA UDI
Identifiers
- Catalog Number
- P807178 FDA UDI
- Primary DI / UDI-DI
- 09321502040891 FDA UDI
- 510(k) Number
- K171088 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
- 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
Yes
FDA UDI
Category: Bone-conduction hearing implant system sound processor/vibrator
Baha SoundArc Extra Large by Cochlear — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bone-conduction hearing implant system sound processor/vibrator.
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- Cochlear™ Baha® 6 Max Sound Processor, Silver — Cochlear Bone Anchored Solutions AB · Class II
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Cleared under the same submission
K171088 also covers:
- Baha SoundArc Connector disc — Cochlear
- Baha SoundArc Fun Colour Kit — Cochlear
- Baha SoundArc Hair Matching Colour Kit — Cochlear
- Baha SoundArc Large — Cochlear
- Baha SoundArc Medium — Cochlear
- Baha SoundArc Small — Cochlear
- Baha Softband bilateral, Black — Cochlear Bone Anchored Solutions AB
- Baha Softband bilateral, Blonde — Cochlear Bone Anchored Solutions AB
- Baha Softband bilateral, Brown — Cochlear Bone Anchored Solutions AB
- Baha Softband bilateral, Dark blue — Cochlear Bone Anchored Solutions AB
- Baha Softband bilateral, Jungle — Cochlear Bone Anchored Solutions AB
- Baha Softband bilateral, Light blue — Cochlear Bone Anchored Solutions AB
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
Sources (1)
- FDA UDI fcc66c9d-8a5d-4a4c-b69e-8f7bb3d61cca 36 fields · synced Jun 1, 2026