Identity
- Trade Name
- HiRes 90K™ HiFocus™ 1J Electrode Instrument Kit FDA UDI
- Generic Name
- Cochlear implant system FDA UDI
- Model / Reference
- CI-4504 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840094454415 FDA UDI07630016810039 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
- In Commercial Distribution FDA UDINot in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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 UDIFDA 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
Moist Heat or Steam Sterilization FDA UDI
Category: Cochlear implant system
HiRes 90K™ HiFocus™ 1J Electrode Instrument Kit by Advanced Bionics — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cochlear implant system.
Cleared under the same submission
P960058 also covers:
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- Chorus™ Sound Processor — Advanced Bionics
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- 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 52bd3844-9460-4c97-879e-26f244321646 34 fields · synced Jun 6, 2026
- FDA UDI 89f97b30-1486-47a5-a448-307570a600f0 35 fields · synced May 27, 2026