BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    emPOWER

    DI: B155EM40 · Model: em4 · BIONX MEDICAL TECHNOLOGIES, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    emPOWER
    Primary DI
    B155EM40
    Version / Model
    em4
    Company Name
    BIONX MEDICAL TECHNOLOGIES, INC.
    Labeler DUNS
    788290471
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-10-27
    Public Version
    3
    Public Version Date
    2020-08-20
    Public Version Status
    Update
    Public Device Record Key
    32af9551-fabb-4eb9-9bcc-30ea0935798c

    Device Description

    Wireless Tuning Device

    Device Characteristics

    Single Use
    No
    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
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    Yes
    Has Serial Number
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    ISW Assembly, Knee/Shank/Ankle/Foot, External

    GMDN Terms

    Code Name
    38453 Portable computer

    Identifiers

    Type ID
    Primary B155EM40