Identity
- Trade Name
- Otomag™ Alpha 2 Sound Processor FDA UDI
- Generic Name
- Head-worn bone-conduction hearing aid implantable magnet FDA UDI
- Device Name
- MAGNETIC IMPLANT S0521-00 STER MRI COND FDA UDI
- Model / Reference
- S0521-00 FDA UDI
- Description
- MAGNETIC IMPLANT S0521-00 STER MRI COND FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00643169645325 FDA UDI
- 510(k) Number
- K132189 FDA UDI
- FDA Product Code
- LXB FDA UDI
- GMDN Term
- Head-worn bone-conduction hearing aid implantable magnet FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.3302 FDA UDI
- Commercial Distribution
- Not 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
Yes
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Otomag™ Alpha 2 Sound Processor by Medtronic Xomed, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 II | Pending data |
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Manufacturer
- Manufacturer
- Medtronic Xomed, Inc.
Sources (1)
- FDA UDI 12c12687-5359-4d5e-aba2-25d80b9bbb94 37 fields · synced Jun 1, 2026