BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Electrode LIPO

    DI: 08809495931187 · Model: AE40-300 · Chungwoo Co., Ltd.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Electrode LIPO
    Primary DI
    08809495931187
    Version / Model
    AE40-300
    Company Name
    Chungwoo Co., Ltd.
    Labeler DUNS
    689894533
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-06-25
    Public Version
    2
    Public Version Date
    2024-08-30
    Public Version Status
    Update
    Public Device Record Key
    0f1695f4-fcf1-4ff6-81f5-fa0ac51be5e2
    Distribution End Date
    2024-08-30

    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
    Yes
    Sterilization Methods
    Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    GEI Electrosurgical, Cutting & Coagulation & Accessories

    GMDN Terms

    Code Name
    61870 Open-surgery electrosurgical handpiece/electrode, monopolar, reusable

    Identifiers

    Type ID
    Primary 08809495931187

    Customer Contacts

    Phone
    +827052091112
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K222709 000