BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Monarch Advanced Imaging Accessory Kit

    DI: B634MON0007090 · Model: MON-000709 · AURIS HEALTH, INC.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Monarch Advanced Imaging Accessory Kit
    Primary DI
    B634MON0007090
    Version / Model
    MON-000709
    Catalog Number
    MON-000709
    Company Name
    AURIS HEALTH, INC.
    Labeler DUNS
    015823456
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-07-15
    Public Version
    2
    Public Version Date
    2023-06-19
    Public Version Status
    Update
    Public Device Record Key
    e66064c2-93bf-4afd-9cfc-568c532fe6bd

    Device Description

    Window Field Generator, Connection Cable, Mounting System

    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
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    Yes
    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
    38678 Robotic surgical arm system

    Identifiers

    Type ID
    Package B634MON0007091
    Primary B634MON0007090

    Premarket Submissions

    Submission Number Supplement Number
    K211493 000