BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    25K P10 UNIVERSAL INSERT

    DI: 04719873120079 · Model: TM0006-162R · BONART CO., LTD.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    25K P10 UNIVERSAL INSERT
    Primary DI
    04719873120079
    Version / Model
    TM0006-162R
    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
    3
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    d74f8aee-a486-4227-8f59-11fe9fd97447

    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
    Yes
    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
    ELC Scaler, Ultrasonic

    GMDN Terms

    Code Name
    36047 Ultrasonic dental scaling/debridement system

    Identifiers

    Type ID
    Primary 04719873120079

    Premarket Submissions

    Submission Number Supplement Number
    K000510 000