BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    REFINE

    DI: 06971560453428 · Model: MaxFill-P · Guilin Refine Medical Instrument Co.,LTD.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    REFINE
    Primary DI
    06971560453428
    Version / Model
    MaxFill-P
    Company Name
    Guilin Refine Medical Instrument Co.,LTD.
    Labeler DUNS
    407578472
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-09-22
    Public Version
    1
    Public Version Date
    2022-09-30
    Public Version Status
    New
    Public Device Record Key
    3cf9428f-1a46-47e8-8862-d50ff1335cbb

    Device Description

    Endodontic obturation system

    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
    Yes
    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
    EKR Plugger, Root Canal, Endodontic

    GMDN Terms

    Code Name
    45247 Endodontic obturation system

    Identifiers

    Type ID
    Primary 06971560453428