BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Pro-X1

    DI: 05397283000182 · Model: XNI-020 · X-BOLT ORTHOPEDICS INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Pro-X1
    Primary DI
    05397283000182
    Version / Model
    XNI-020
    Company Name
    X-BOLT ORTHOPEDICS INC.
    Labeler DUNS
    119116284
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-08-27
    Public Version
    1
    Public Version Date
    2024-09-04
    Public Version Status
    New
    Public Device Record Key
    6f2a00fe-758e-4049-bc41-d04bf1cf35d8

    Device Description

    T20 Torx screwdriver (4.5Nm Torque Limit)

    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
    No
    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
    HSB Rod, Fixation, Intramedullary And Accessories

    GMDN Terms

    Code Name
    33968 Surgical screwdriver, reusable

    Identifiers

    Type ID
    Primary 05397283000182