Identity
- Trade Name
- HiRes™ Ultra 3D Replacement Magnet FDA UDI
- Generic Name
- Cochlear implant implantable magnet FDA UDI
- Model / Reference
- CI-1419 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840094456297 FDA UDI
- PMA Number
- P960058 FDA UDI
- FDA Product Code
- MCM FDA UDI
- GMDN Term
- Cochlear implant implantable magnet FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- In 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
MR Conditional FDA UDI
Category: Cochlear implant implantable magnet
HiRes™ Ultra 3D Replacement Magnet by Advanced Bionics — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cochlear implant implantable magnet.
- CI24RE Series Sterile Replacement Magnet — Cochlear · Class III
- Cochlear™ Magnet Cassette — Cochlear · Class II
- CI500 Series Sterile Replacement Magnet — Cochlear · Class III
- Cochlear™ Sterile Replacement Magnet — Cochlear · Class II
- HiRes 90K™ Replacement Magnet — Advanced Bionics · Class III
Cleared under the same submission
P960058 also covers:
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- 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Advanced Bionics
Sources (1)
- FDA UDI 0a19d88b-2263-413f-95ad-2a1241401899 34 fields · synced May 30, 2026