BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Verge

    DI: D915K21061 · Model: K2106 · Plastcare USA
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    6

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    Basic Information

    Brand Name
    Verge
    Primary DI
    D915K21061
    Version / Model
    K2106
    Company Name
    Plastcare USA
    Labeler DUNS
    079299604
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    6
    Record Status
    Published
    Publish Date
    2020-03-10
    Public Version
    1
    Public Version Date
    2020-03-18
    Public Version Status
    New
    Public Device Record Key
    20a1b951-4d66-4b6f-b816-bf306a6d97fb

    Device Description

    Stainless Steel K File Size 6 Length 21

    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
    MR Safe
    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
    Package D915K21062
    Primary D915K21061
    Unit of Use D915K21060