BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Resonance

    DI: 08051597160549 · Model: RE-VO2 + CRADLE · M.R.S. SRL
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Resonance
    Primary DI
    08051597160549
    Version / Model
    RE-VO2 + CRADLE
    Catalog Number
    4300103540
    Company Name
    M.R.S. SRL
    Labeler DUNS
    514071869
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-09-03
    Public Version
    1
    Public Version Date
    2025-09-11
    Public Version Status
    New
    Public Device Record Key
    e628fe5c-38c1-496a-86a2-2f0064033fab

    Device Description

    USB VIDEO OTOSCOPE COMPLETE WITH CRADLE

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    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
    Yes
    Has Serial Number
    Yes
    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
    ERA Otoscope

    GMDN Terms

    Code Name
    65129 Video otoscope/audiometer

    Identifiers

    Type ID
    Primary 08051597160549