BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    XACT Robotics: Harness (L)

    DI: 07290017702186 · Model: A · XACT ROBOTICS LTD
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    XACT Robotics: Harness (L)
    Primary DI
    07290017702186
    Version / Model
    A
    Catalog Number
    XR-LG-HRN
    Company Name
    XACT ROBOTICS LTD
    Labeler DUNS
    600405981
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-01-19
    Public Version
    1
    Public Version Date
    2023-01-27
    Public Version Status
    New
    Public Device Record Key
    9f719ed5-e877-487e-8201-974f76ea27bb

    Device Description

    Large Harness

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

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    JAK System, X-Ray, Tomography, Computed

    GMDN Terms

    Code Name
    61131 Radiological general body-part positioner

    Identifiers

    Type ID
    Primary 07290017702186
    Package 17290017702183

    Customer Contacts

    Phone
    +18883179228
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K191332 000