BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    ProShape One Gutta Percha Large

    DI: 10810138822286 · Model: SDGP40061 · Endo Direct LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    ProShape One Gutta Percha Large
    Primary DI
    10810138822286
    Version / Model
    SDGP40061
    Company Name
    Endo Direct LLC
    Labeler DUNS
    125216703
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-07-15
    Public Version
    2
    Public Version Date
    2024-11-15
    Public Version Status
    Update
    Public Device Record Key
    d2f8032c-6f0d-4c6e-b198-73de5e062b81
    Distribution End Date
    2024-11-14

    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
    Yes
    PM Exempt
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    No
    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
    45081 Synthetic gutta-percha

    Identifiers

    Type ID
    Primary 10810138822286