BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    GuttaCore Obturators

    DI: D716TNSRBGC6000501 · Model: TNSRBGC600050 · TULSA DENTAL PRODUCTS LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    6

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    Basic Information

    Brand Name
    GuttaCore Obturators
    Primary DI
    D716TNSRBGC6000501
    Version / Model
    TNSRBGC600050
    Catalog Number
    TNSRBGC600050
    Company Name
    TULSA DENTAL PRODUCTS LLC
    Labeler DUNS
    942778564
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    6
    Record Status
    Published
    Publish Date
    2024-03-25
    Public Version
    1
    Public Version Date
    2024-04-02
    Public Version Status
    New
    Public Device Record Key
    58307692-0d9d-422d-b677-b64273c75e7e

    Device Description

    GuttaCore for RECIPROC Blue R50

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    Yes
    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
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    EKM GUTTA-PERCHA

    GMDN Terms

    Code Name
    31872 Natural gutta-percha

    Identifiers

    Type ID
    Unit of Use D716TNSRBGC6000500
    Primary D716TNSRBGC6000501