BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    STELLAR Knee

    DI: 00850046497100 · Model: Software Version 1.2.2 · POLARISAR, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    STELLAR Knee
    Primary DI
    00850046497100
    Version / Model
    Software Version 1.2.2
    Catalog Number
    70-0001
    Company Name
    POLARISAR, INC.
    Labeler DUNS
    035071717
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-03-03
    Public Version
    1
    Public Version Date
    2025-03-11
    Public Version Status
    New
    Public Device Record Key
    dc89393d-6ca5-4873-853c-41660ff8d510

    Device Description

    STELLAR Knee Application

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    Yes
    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
    No
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    OLO Orthopedic Stereotaxic Instrument

    GMDN Terms

    Code Name
    45200 Orthopaedic stereotactic surgery system

    Identifiers

    Type ID
    Primary 00850046497100