BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    RealGUIDE Z3D Surgical Kit

    DI: 08050038834407 · Model: 3DM0070ZUS · 3DIEMME SRL
    View on AccessGUDID
    Product Codes
    0
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    RealGUIDE Z3D Surgical Kit
    Primary DI
    08050038834407
    Version / Model
    3DM0070ZUS
    Company Name
    3DIEMME SRL
    Labeler DUNS
    857172105
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2026-03-10
    Public Version
    1
    Public Version Date
    2026-03-18
    Public Version Status
    New
    Public Device Record Key
    2672a24c-2f69-439e-aac0-381a17bd439a

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    Yes
    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
    Yes
    Sterilization Methods
    Moist Heat or Steam Sterilization

    GMDN Terms

    Code Name
    45147 Dental/maxillofacial surgical procedure kit, non-medicated, reusable

    Identifiers

    Type ID
    Primary 08050038834407