BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Darby Dental Supply, LLC

    DI: 00889813060261 · Model: 5255578 · DARBY DENTAL SUPPLY, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    6

    Basic Information

    Brand Name
    Darby Dental Supply, LLC
    Primary DI
    00889813060261
    Version / Model
    5255578
    Catalog Number
    5255578
    Company Name
    DARBY DENTAL SUPPLY, LLC
    Labeler DUNS
    825137818
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    6
    Record Status
    Published
    Publish Date
    2023-09-12
    Public Version
    1
    Public Version Date
    2023-09-20
    Public Version Status
    New
    Public Device Record Key
    995d1cac-52c3-491c-b940-f224ab2229a0

    Device Description

    TRIPLE-FLEX K FILES #30 21MM

    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
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    EKS FILE, PULP CANAL, ENDODONTIC

    GMDN Terms

    Code Name
    31878 Manual endodontic file/rasp, reusable

    Identifiers

    Type ID
    Unit of Use 10889813060268
    Primary 00889813060261