BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    X-CUBE

    DI: 08809260471016 · Model: X-CUBE #14 · Saeshin Precision Co., Ltd.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    X-CUBE
    Primary DI
    08809260471016
    Version / Model
    X-CUBE #14
    Company Name
    Saeshin Precision Co., Ltd.
    Labeler DUNS
    688019566
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-01-22
    Public Version
    1
    Public Version Date
    2020-01-30
    Public Version Status
    New
    Public Device Record Key
    86a33902-79a7-436f-9b9a-02e44356f490

    Device Description

    64:1, Contra Angle(Button Type #1) X-CUBE(C/B)+X-CUBE(Foot Controller)+Forte 100αEI+ACL(B)-43I

    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
    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
    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
    EBW Controller, Foot, Handpiece And Cord

    GMDN Terms

    Code Name
    45572 Dental power tool system, line-powered

    Identifiers

    Type ID
    Primary 08809260471016

    Premarket Submissions

    Submission Number Supplement Number
    K092758 000