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    FDA UDI In Commercial Distribution 🇺🇸 United States

    Metalogix Revolution

    DI: 00850069061234 · Model: 105400 · FUSION ORTHOPEDICS, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Metalogix Revolution
    Primary DI
    00850069061234
    Version / Model
    105400
    Catalog Number
    105400
    Company Name
    FUSION ORTHOPEDICS, LLC
    Labeler DUNS
    080307067
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-11-11
    Public Version
    1
    Public Version Date
    2025-11-19
    Public Version Status
    New
    Public Device Record Key
    368d40ae-72bf-4f5a-ba4c-43c9cbf24354

    Device Description

    Super Strut Long 172mm/350mm

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

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    HWN Instrument, Compression

    GMDN Terms

    Code Name
    56640 Orthopaedic implant-instrument extension adaptor, single-use

    Identifiers

    Type ID
    Primary 00850069061234