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    FDA UDI In Commercial Distribution 🇺🇸 United States

    GuttaCore

    DI: D716GCSV6451 · Model: GCSV645 · TULSA DENTAL PRODUCTS LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    GuttaCore
    Primary DI
    D716GCSV6451
    Version / Model
    GCSV645
    Catalog Number
    GCSV645
    Company Name
    TULSA DENTAL PRODUCTS LLC
    Labeler DUNS
    942778564
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-08-30
    Public Version
    1
    Public Version Date
    2022-09-07
    Public Version Status
    New
    Public Device Record Key
    92c51e2b-698d-45f2-8853-90344eb79e33

    Device Description

    Verifier: GuttaCore NT45/25mm

    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
    Yes
    Sterilization Methods
    Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    EIL GAUGE, DEPTH, INSTRUMENT, DENTAL

    GMDN Terms

    Code Name
    31878 Manual endodontic file/rasp, reusable

    Identifiers

    Type ID
    Primary D716GCSV6451