Identity
- Trade Name
- Alpha 2 MPO ePlus FDA UDI
- Generic Name
- Bone-conduction hearing aid, head-worn FDA UDI
- Device Name
- PROCESSOR S0821-02 ALPHA2MPOR ANTHRACITE FDA UDI
- Model / Reference
- S0821-02 FDA UDI
- Description
- PROCESSOR S0821-02 ALPHA2MPOR ANTHRACITE FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00643169862234 FDA UDI
- 510(k) Number
- K153391 FDA UDI
- FDA Product Code
- LBX FDA UDI
- GMDN Term
- Bone-conduction hearing aid, head-worn FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.4530 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Alpha 2 MPO ePlus 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 ee1302f2-98c6-43bf-adbd-b016431da974 37 fields · synced Jun 6, 2026