BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Otomag™ Alpha (M) Magnetic Implant

    DI: 00643169644632 · Model: S0521-01 · MEDTRONIC XOMED, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Otomag™ Alpha (M) Magnetic Implant
    Primary DI
    00643169644632
    Version / Model
    S0521-01
    Company Name
    MEDTRONIC XOMED, INC.
    Labeler DUNS
    835465063
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-04-15
    Public Version
    4
    Public Version Date
    2019-02-15
    Public Version Status
    Update
    Public Device Record Key
    c9a235bf-8110-400e-a276-170b47c1d738
    Distribution End Date
    2018-10-24

    Device Description

    IMPLANT S0521-01 MAGNETIC STER MRI UNSAF

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    MR Unsafe
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    LXB Hearing aid, bone conduction

    GMDN Terms

    Code Name
    61744 Head-worn bone-conduction hearing aid implantable magnet

    Identifiers

    Type ID
    Primary 00643169644632

    Customer Contacts

    Phone
    +1(800)633-8766
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K132189 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    -20 – 50 Degrees Celsius