BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Monarch™ Software Cart v2.2.5

    DI: 10810068810773 · Model: Version 2.2.5 · AURIS HEALTH, INC.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Monarch™ Software Cart v2.2.5
    Primary DI
    10810068810773
    Version / Model
    Version 2.2.5
    Company Name
    AURIS HEALTH, INC.
    Labeler DUNS
    015823456
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-02-16
    Public Version
    1
    Public Version Date
    2024-02-26
    Public Version Status
    New
    Public Device Record Key
    0ea10671-280b-4d0a-a2bf-42909df629d6

    Device Description

    Monarch™ Software Cart v2.2.5

    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
    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
    EOQ Bronchoscope (Flexible Or Rigid)
    JAK System, X-Ray, Tomography, Computed

    GMDN Terms

    Code Name
    43265 Robotic surgical system application software

    Identifiers

    Type ID
    Primary 10810068810773

    Premarket Submissions

    Submission Number Supplement Number
    K211493 000