BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    SonicOne Clinic

    DI: 00841626100992 · Model: E-SOP-HP · MISONIX, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    SonicOne Clinic
    Primary DI
    00841626100992
    Version / Model
    E-SOP-HP
    Company Name
    MISONIX, INC.
    Labeler DUNS
    065963449
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-24
    Public Version
    3
    Public Version Date
    2018-07-24
    Public Version Status
    Update
    Public Device Record Key
    33499a72-6e3c-4260-af4b-0da0f2491dce

    Device Description

    SonicOne Clinic Handpiece

    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
    Yes
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    Yes
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    LFL Instrument, Ultrasonic Surgical

    GMDN Terms

    Code Name
    60717 Hard-tissue ultrasonic surgical system handpiece

    Identifiers

    Type ID
    Primary 00841626100992