BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    EdgeEndo

    DI: 00810213810071 · Model: EUCF1525 · HSG-S Corp.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    6

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    Basic Information

    Brand Name
    EdgeEndo
    Primary DI
    00810213810071
    Version / Model
    EUCF1525
    Company Name
    HSG-S Corp.
    Labeler DUNS
    144949235
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    6
    Record Status
    Published
    Publish Date
    2026-03-23
    Public Version
    1
    Public Version Date
    2026-03-31
    Public Version Status
    New
    Public Device Record Key
    6cea1ce7-c8fb-455c-9105-a2bbd9cc5dd6

    Device Description

    EdgeUtopia C-File, Size 15, 25mm

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    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
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    EKS FILE, PULP CANAL, ENDODONTIC

    GMDN Terms

    Code Name
    63720 Manual endodontic file/rasp, single-use

    Identifiers

    Type ID
    Unit of Use 80810213810077
    Primary 00810213810071