BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Thermafil for GT

    DI: J003GTOB400461 · Model: GTOB40046 · MAILLEFER INSTRUMENTS HOLDING Sàrl
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Thermafil for GT
    Primary DI
    J003GTOB400461
    Version / Model
    GTOB40046
    Catalog Number
    GTOB40046
    Company Name
    MAILLEFER INSTRUMENTS HOLDING Sàrl
    Labeler DUNS
    480538495
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2026-03-26
    Public Version
    1
    Public Version Date
    2026-04-03
    Public Version Status
    New
    Public Device Record Key
    5bd1ce3d-bc6f-49f9-bd95-3d121c734dd5

    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
    EKM GUTTA-PERCHA

    GMDN Terms

    Code Name
    47751 Warm-bonded endodontic obturation system obturator

    Identifiers

    Type ID
    Primary J003GTOB400461

    Storage Conditions

    Type
    Special Storage Condition, Specify
    Special Conditions
    up to 86°F