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    FDA UDI In Commercial Distribution 🇺🇸 United States

    LEONE SPA

    DI: 08033707103240 · Model: A0640-18D · LEONE SPA
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    LEONE SPA
    Primary DI
    08033707103240
    Version / Model
    A0640-18D
    Catalog Number
    A0640-18D
    Company Name
    LEONE SPA
    Labeler DUNS
    432167294
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-04-23
    Public Version
    1
    Public Version Date
    2025-05-01
    Public Version Status
    New
    Public Device Record Key
    c0b1f728-4837-49b9-b0f8-9660ff5e5c2c

    Device Description

    TELESCOPIC EXPANDER CAD-CAM 18mm .

    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
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    DYJ Retainer, Screw Expansion, Orthodontic
    JEX Plier, Orthodontic

    GMDN Terms

    Code Name
    35310 Orthodontic retainer

    Identifiers

    Type ID
    Primary 08033707103240