BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    DISPOSABLE KIT FOR CIRQ WITH ROBOTIC ALIGNMENT MODULE

    DI: 04056481141660 · Model: 56101 · Brainlab AG
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    DISPOSABLE KIT FOR CIRQ WITH ROBOTIC ALIGNMENT MODULE
    Primary DI
    04056481141660
    Version / Model
    56101
    Company Name
    Brainlab AG
    Labeler DUNS
    314482980
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-01-11
    Public Version
    3
    Public Version Date
    2024-01-04
    Public Version Status
    Update
    Public Device Record Key
    e030f358-9b0b-4174-ab8b-1f06f132dae0
    Distribution End Date
    2023-05-16

    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
    OLO Orthopedic Stereotaxic Instrument
    HAW Neurological Stereotaxic Instrument

    GMDN Terms

    Code Name
    62380 Surgical instrument assist arm system, power-adjusted

    Identifiers

    Type ID
    Primary 04056481141660

    Premarket Submissions

    Submission Number Supplement Number
    K202320 000
    K210989 000