BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    360CAS

    DI: B432360CAS01200 · Model: KIC-DND-0120 · 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
    360CAS
    Primary DI
    B432360CAS01200
    Version / Model
    KIC-DND-0120
    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
    2023-10-20
    Public Version
    1
    Public Version Date
    2023-10-30
    Public Version Status
    New
    Public Device Record Key
    ae2f9e2d-be5e-4e15-96df-837ed8772722

    Device Description

    Resection Plane 90

    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
    MR Unsafe
    Direct Marking Exempt
    Yes
    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
    OLO Orthopedic Stereotaxic Instrument

    GMDN Terms

    Code Name
    42895 Robotic surgical navigation system application software

    Identifiers

    Type ID
    Primary B432360CAS01200

    Premarket Submissions

    Submission Number Supplement Number
    K223927 000