BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    POINT ROBOTICS MEDTECH INC.

    DI: 04719881650582 · Model: PSHF01-310 · POINT ROBOTICS MEDTECH INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    POINT ROBOTICS MEDTECH INC.
    Primary DI
    04719881650582
    Version / Model
    PSHF01-310
    Company Name
    POINT ROBOTICS MEDTECH INC.
    Labeler DUNS
    656383289
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2026-04-09
    Public Version
    1
    Public Version Date
    2026-04-17
    Public Version Status
    New
    Public Device Record Key
    cf4f93ba-1b75-4f02-9914-0676183bd488

    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
    Yes
    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
    OLO Orthopedic Stereotaxic Instrument

    GMDN Terms

    Code Name
    45200 Orthopaedic stereotactic surgery system

    Identifiers

    Type ID
    Primary 04719881650582

    Premarket Submissions

    Submission Number Supplement Number
    K230087 000
    K241130 000
    K252989 000