BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Cartridge (box) containing one pot with Digital Sensor Cone Positioner

    DI: 07898561549150 · Model: PriZma 3D Bio Ortho · Maquira Industria de Produtos Odontologicos S/A
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Cartridge (box) containing one pot with Digital Sensor Cone Positioner
    Primary DI
    07898561549150
    Version / Model
    PriZma 3D Bio Ortho
    Catalog Number
    80322400150
    Company Name
    Maquira Industria de Produtos Odontologicos S/A
    Labeler DUNS
    679266866
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-09-05
    Public Version
    1
    Public Version Date
    2025-09-15
    Public Version Status
    New
    Public Device Record Key
    7a5ba5e2-3d3b-4169-9a49-2e55f0981e7c

    Device Description

    Cone Positioner for Digital Sensor is a polyacetal-based product indicated for the precise orientation of X-ray machines in dental procedures.

    Device Characteristics

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

    Product Codes

    Code Name
    EGZ Holder, Film, X-Ray

    GMDN Terms

    Code Name
    61131 Radiological general body-part positioner

    Identifiers

    Type ID
    Primary 07898561549150