BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    XP-4D

    DI: 08800069204805 · Model: GP-Starter · SURE DENT CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    60

    Let the assistant research this device

    The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Brand Name
    XP-4D
    Primary DI
    08800069204805
    Version / Model
    GP-Starter
    Company Name
    SURE DENT CORPORATION
    Labeler DUNS
    688273010
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    60
    Record Status
    Published
    Publish Date
    2025-01-07
    Public Version
    3
    Public Version Date
    2025-02-25
    Public Version Status
    Update
    Public Device Record Key
    44506096-5cbf-41e2-b34b-ea4e2fd6a324
    Distribution End Date
    2025-01-31

    Device Description

    XP-4D Bio Gutta-Percha Cones STARTER

    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
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    EKM Gutta-Percha

    GMDN Terms

    Code Name
    45081 Synthetic gutta-percha

    Identifiers

    Type ID
    Unit of Use 88800069204801
    Primary 08800069204805