BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    MEGA5.5 SPINE SYSTEM

    DI: 08809763500343 · Model: 81633 · BK MEDITECH CO.,LTD.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    MEGA5.5 SPINE SYSTEM
    Primary DI
    08809763500343
    Version / Model
    81633
    Company Name
    BK MEDITECH CO.,LTD.
    Labeler DUNS
    687941818
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-06-23
    Public Version
    1
    Public Version Date
    2023-07-03
    Public Version Status
    New
    Public Device Record Key
    b7f898de-baa0-48b4-a916-45699039ef62

    Device Description

    Wrench 4.0

    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
    No
    Has Donation ID
    No

    Sterilization

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

    Product Codes

    Code Name
    HXC Wrench

    GMDN Terms

    Code Name
    32871 Surgical torque wrench, reusable

    Identifiers

    Type ID
    Primary 08809763500343