BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Disposable brush tips (white)

    DI: EKUR000968KA1 · Model: #968-KA · KURARAY NORITAKE DENTAL INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    50

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    Basic Information

    Brand Name
    Disposable brush tips (white)
    Primary DI
    EKUR000968KA1
    Version / Model
    #968-KA
    Company Name
    KURARAY NORITAKE DENTAL INC.
    Labeler DUNS
    697119498
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    50
    Record Status
    Published
    Publish Date
    2025-08-22
    Public Version
    1
    Public Version Date
    2025-09-01
    Public Version Status
    New
    Public Device Record Key
    77a7d9cc-04cb-4a49-a946-6647235ad93b

    Device Characteristics

    Single Use
    Yes
    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
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    KXR Applicator, Resin

    GMDN Terms

    Code Name
    35697 Dental material application tool, single-use

    Identifiers

    Type ID
    Unit of Use EKUR000968KA0
    Primary EKUR000968KA1