BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    FILE-RITE™

    DI: D701FILE2 · Model: FILE · PULPDENT CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    FILE-RITE™
    Primary DI
    D701FILE2
    Version / Model
    FILE
    Company Name
    PULPDENT CORPORATION
    Labeler DUNS
    001006089
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-08-11
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    7cf9075f-9046-4a9f-8622-ee306bb83f14

    Device Description

    KIT: 4 x 5 gm syringes File-Rite + 50 applicator tips Canal Lubricant and Chelating Agent

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    Yes
    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
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    EKL Point, Silver, Endodontic

    GMDN Terms

    Code Name
    45233 Endodontic reaming aid material

    Identifiers

    Type ID
    Primary D701FILE2