BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    NxSTEP

    DI: 00718175004807 · Model: 945-480 · BIODEX MEDICAL SYSTEMS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    NxSTEP
    Primary DI
    00718175004807
    Version / Model
    945-480
    Catalog Number
    945-480
    Company Name
    BIODEX MEDICAL SYSTEMS, INC.
    Labeler DUNS
    043833813
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-05-15
    Public Version
    1
    Public Version Date
    2019-05-23
    Public Version Status
    New
    Public Device Record Key
    ab3f9ba9-51d8-4769-9e26-07c3724b3b38

    Device Description

    NxSTEP Unweighing System

    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
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    ITJ Walker, Mechanical

    GMDN Terms

    Code Name
    61942 Mobile gait rehabilitation system, harness-support

    Identifiers

    Type ID
    Primary 00718175004807