BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Axi+Line Bunion Correction System

    DI: 00817701028185 · Model: AXL-DRV-T10 · Medartis Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Axi+Line Bunion Correction System
    Primary DI
    00817701028185
    Version / Model
    AXL-DRV-T10
    Company Name
    Medartis Inc.
    Labeler DUNS
    192756786
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-11-17
    Public Version
    4
    Public Version Date
    2023-09-29
    Public Version Status
    Update
    Public Device Record Key
    5ec5a9f3-d835-41a6-aa3f-77faad62e70b

    Device Description

    Axi-Line Individual Packaged Driver

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

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    LHX Trousers, Anti-Shock

    GMDN Terms

    Code Name
    33968 Surgical screwdriver, reusable

    Identifiers

    Type ID
    Primary 00817701028185