BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    X-Guide

    DI: 00817421021114 · Model: P010819 · XNAV TECHNOLOGIES LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    X-Guide
    Primary DI
    00817421021114
    Version / Model
    P010819
    Company Name
    XNAV TECHNOLOGIES LLC
    Labeler DUNS
    026096247
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-02-03
    Public Version
    1
    Public Version Date
    2021-02-11
    Public Version Status
    New
    Public Device Record Key
    ee0a7b44-9fa9-469f-8b0f-f3e7797a5789

    Device Description

    TRACKER ARM ASSEMBLY, CLX, ANTERIOR LL

    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
    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
    PLV Dental Stereotaxic Instrument

    GMDN Terms

    Code Name
    61496 Surgical planning/navigation-enhancement system

    Identifiers

    Type ID
    Primary 00817421021114

    Premarket Submissions

    Submission Number Supplement Number
    K150222 000
    K200662 000