Identity
- Trade Name
- Slim HP 3D Magnet FDA UDI
- Generic Name
- Hearing implant system external magnet, reusable FDA UDI
- Device Name
- 3 FDA UDI
- Model / Reference
- CI-7525-003 FDA UDI
- Description
- 3 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07630016880551 FDA UDI
- PMA Number
- P960058 FDA UDI
- FDA Product Code
- MCM FDA UDI
- GMDN Term
- Hearing implant system external magnet, reusable FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- Not 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
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Slim HP 3D 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 (1)
- FDA UDI c8a58de6-8cb1-4441-9f89-0e9d3f7a4a31 37 fields · synced Jun 1, 2026