BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Imagine Zirconia

    DI: 00817340025552 · Model: Imagine Zr Multilayered B4 98x14mm Disc · JENSEN INDUSTRIES INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Imagine Zirconia
    Primary DI
    00817340025552
    Version / Model
    Imagine Zr Multilayered B4 98x14mm Disc
    Catalog Number
    I84F4
    Company Name
    JENSEN INDUSTRIES INC.
    Labeler DUNS
    060018587
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-10-02
    Public Version
    2
    Public Version Date
    2024-03-25
    Public Version Status
    Update
    Public Device Record Key
    5c5cb0c9-3ca9-48bf-8109-57b78ebc1a89
    Distribution End Date
    2020-11-27

    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
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    EIH Powder, Porcelain

    GMDN Terms

    Code Name
    16187 Dental appliance fabrication material, ceramic

    Identifiers

    Type ID
    Primary 00817340025552