Identity
- Trade Name
- Colour Cover, Maize (3 pcs) FDA UDI
- Generic Name
- Bone-conduction hearing implant system sound processor/vibrator FDA UDI
- Model / Reference
- 96005 FDA UDI
Identifiers
- Catalog Number
- 96005 FDA UDI
- Primary DI / UDI-DI
- 09321502034067 FDA UDI
- 510(k) Number
- K042017 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
No
FDA UDI
Category: Bone-conduction hearing implant system sound processor/vibrator
Colour Cover, Maize (3 pcs) by Cochlear Bone Anchored Solutions AB — 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.
- Baha SoundArc Hair Matching Colour Kit — Cochlear · Class II
- SAMBA 2 BB AP Unit, right — Med-El Elektromedizinische Geräte Gesellschaft m.b.H. · Class II
- SAMBA 2 BB PoM, left — Med-El Elektromedizinische Geräte Gesellschaft m.b.H. · Class II
- SAMBA 2 BB PoM, right — Med-El Elektromedizinische Geräte Gesellschaft m.b.H. · Class II
- SAMBA 2 BB User Kit, right — Med-El Elektromedizinische Geräte Gesellschaft m.b.H. · Class II
- Baha 5 Power, Black — Cochlear Bone Anchored Solutions AB · Class II
- Baha 5 SuperPower Bodyworn cable — Cochlear Bone Anchored Solutions AB · Class II
- Baha — Cochlear Bone Anchored Solutions AB · Class II
Cleared under the same submission
K042017 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Cochlear Bone Anchored Solutions AB
Sources (1)
- FDA UDI 26d5526a-f55a-45f8-b559-1f3dce0c4a45 35 fields · synced May 30, 2026