BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    MotionSense Knee Alignment Block

    DI: 15060808320115 · Model: 007-00068-US · ENMOVI LTD
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    MotionSense Knee Alignment Block
    Primary DI
    15060808320115
    Version / Model
    007-00068-US
    Catalog Number
    007-00068-US
    Company Name
    ENMOVI LTD
    Labeler DUNS
    225424353
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-07-15
    Public Version
    2
    Public Version Date
    2023-10-17
    Public Version Status
    Update
    Public Device Record Key
    0831c14f-1fff-40ba-bb5e-673bbf270a40

    Device Description

    MotionSense Knee Alignment Block

    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
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    KQX Goniometer, Ac-Powered

    GMDN Terms

    Code Name
    33652 Electronic goniometer/kinesiology sensor

    Identifiers

    Type ID
    Primary 15060808320115

    Storage Conditions

    Type
    Handling Environment Temperature
    Temperature Range
    0 – 25 Degrees Celsius
    Type
    Handling Environment Humidity
    Temperature Range
    15 – 75 Percent (%) Relative Humidity