Identity
- Trade Name
- HiRes 90K™ Replacement Magnet FDA UDI
- Generic Name
- Cochlear implant system FDA UDI
- Model / Reference
- CI-1412 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07630016809910 FDA UDI00840094456525 FDA UDI
- PMA Number
- P960058 FDA UDI
- FDA Product Code
- MCM FDA UDI
- GMDN Term
- Cochlear implant system FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDIIn Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
HiRes 90K™ Replacement Magnet by Advanced Bionics — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Advanced Bionics
Sources (2)
- FDA UDI b0df618b-a4f3-40a0-859e-d82e58ec849d 35 fields · synced May 30, 2026
- FDA UDI f2bb5b51-dd75-4e4c-a719-2bb01a035aa1 34 fields · synced May 27, 2026