BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    T1 Diamond shaped electrode

    DI: 04719873120468 · Model: T1 · BONART CO., LTD.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    T1 Diamond shaped electrode
    Primary DI
    04719873120468
    Version / Model
    T1
    Company Name
    BONART CO., LTD.
    Labeler DUNS
    657263687
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-20
    Public Version
    4
    Public Version Date
    2023-04-04
    Public Version Status
    Update
    Public Device Record Key
    ae198caa-c867-4d2d-9ea0-5ecae3ae7ae4

    Device Characteristics

    Single Use
    No
    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
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    No
    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
    EKZ Unit, Electrosurgical, And Accessories, Dental

    GMDN Terms

    Code Name
    44776 Electrosurgical system

    Identifiers

    Type ID
    Primary 04719873120468

    Premarket Submissions

    Submission Number Supplement Number
    K020080 000