BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    HARMONICA

    DI: 08054187381140 · Model: HARMONICA · INVENTIS SRL
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    HARMONICA
    Primary DI
    08054187381140
    Version / Model
    HARMONICA
    Catalog Number
    11205
    Company Name
    INVENTIS SRL
    Labeler DUNS
    338454995
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-12-11
    Public Version
    1
    Public Version Date
    2023-12-19
    Public Version Status
    New
    Public Device Record Key
    40db5c64-c5b3-4224-9c82-a67ca069694c

    Device Description

    Harmonica is a wired digital video-otoscope that integrates a high-definition camera with chip-on-tip and a LED 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
    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
    12849 Otoscope, direct

    Identifiers

    Type ID
    Primary 08054187381140