Identity
- Trade Name
- Naida CI Q90 FDA UDI
- Generic Name
- Cochlear implant/auditory brainstem implant sound processor FDA UDI
- Device Name
- Caribbean Pirate FDA UDI
- Model / Reference
- CI-5280-190 FDA UDI
- Description
- Caribbean Pirate FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840094449886 FDA UDI
- PMA Number
- P960058 FDA UDI
- FDA Product Code
- MCM FDA UDI
- GMDN Term
- Cochlear implant/auditory brainstem implant sound processor FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Contains Latex
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Cochlear implant/auditory brainstem implant sound processor
Discover the Naida CI Q90, a cutting-edge cochlear implant designed for individuals with severe or profound hearing loss. With advanced features and precise engineering, this device offers unparalleled sound restoration and communication capabilities. Learn more about its specifications, installation process, and clinical benefits.
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Cleared under the same submission
P960058 also covers:
- BTE Cable — Advanced Bionics
- Chorus™ Sound Processor — Advanced Bionics
- HiFocus SlimJ Electrode Depth Gauge — Advanced Bionics
- HiRes™ Ultra Recess Gauge — Advanced Bionics
- M Battery — Advanced Bionics
- M Standard Battery — Advanced Bionics
- M Zn-Air Battery Pak — Advanced Bionics
- MRI Antenna Coil Cover — Advanced Bionics
- Naida CI Q90 — Advanced Bionics
- Naida™ CI M30 — Advanced Bionics
- Naida™ CI M90 Sound Processor — Advanced Bionics
- Neptune™ Cable for AquaMic™ — Advanced Bionics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Advanced Bionics
Sources (1)
- FDA UDI 65868111-1431-41ce-9402-0539930f671d 36 fields · synced Jul 9, 2026