BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Monarch™ Laptop P17 Software v4.1.0

    DI: 10810068810605 · Model: Version 4.1.0 · Auris Health, Inc.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Monarch™ Laptop P17 Software v4.1.0
    Primary DI
    10810068810605
    Version / Model
    Version 4.1.0
    Company Name
    Auris Health, Inc.
    Labeler DUNS
    015823456
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-03-03
    Public Version
    2
    Public Version Date
    2025-09-01
    Public Version Status
    Update
    Public Device Record Key
    7a4f81c8-606b-4e83-8e00-cc6c2f4c2207

    Device Description

    Monarch™ Laptop P17 Software v4.1.0

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

    GMDN Terms

    Code Name
    43265 Robotic surgical system application software

    Identifiers

    Type ID
    Primary 10810068810605

    Premarket Submissions

    Submission Number Supplement Number
    K243219 000