Identity
- Trade Name
- Auria™ Headpiece FDA UDI
- Generic Name
- Cochlear implant/auditory brainstem implant coil FDA UDI
- Device Name
- Silver Metallic FDA UDI
- Model / Reference
- CI-5304-124 FDA UDI
- Description
- Silver Metallic FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07630016826481 FDA UDI
- PMA Number
- P960058 FDA UDI
- FDA Product Code
- MCM FDA UDI
- GMDN Term
- Cochlear implant/auditory brainstem implant coil 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
Auria™ Headpiece by Advanced Bionics — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
P960058 also covers:
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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 (1)
- FDA UDI 6d848826-a264-4e42-b68c-5b54de282d2f 37 fields · synced May 31, 2026