BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Empower

    DI: 04064409012060 · Model: 1A1-1=L27-8/7-15 · OTTO BOCK HEALTHCARE
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Empower
    Primary DI
    04064409012060
    Version / Model
    1A1-1=L27-8/7-15
    Company Name
    OTTO BOCK HEALTHCARE
    Labeler DUNS
    932133408
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-04-29
    Public Version
    1
    Public Version Date
    2020-05-07
    Public Version Status
    New
    Public Device Record Key
    c3eed684-5b15-4ee0-920e-7cffb7e343c6

    Device Description

    1A1-1 Empower, L, black, brown

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    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
    64725 Mechatronic external ankle-foot prosthesis

    Identifiers

    Type ID
    Primary 04064409012060
    Previous 04032767839391