BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ARVIS ®

    DI: 00850012315940 · Model: IN-50000 · KICO KNEE INNOVATION COMPANY PTY LIMITED
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ARVIS ®
    Primary DI
    00850012315940
    Version / Model
    IN-50000
    Company Name
    KICO KNEE INNOVATION COMPANY PTY LIMITED
    Labeler DUNS
    757918953
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-05-19
    Public Version
    1
    Public Version Date
    2025-05-27
    Public Version Status
    New
    Public Device Record Key
    e58636ad-5b19-4257-9948-9dc5fd9957c6

    Device Description

    ARVIS Global Hip and Knee 2.0 Navigation System

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    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
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    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 00850012315940