BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    SPHERICAL AMALGAM

    DI: D74422905680 · Model: 2290-568 · BENCO DENTAL SUPPLY CO.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    SPHERICAL AMALGAM
    Primary DI
    D74422905680
    Version / Model
    2290-568
    Company Name
    BENCO DENTAL SUPPLY CO.
    Labeler DUNS
    015108087
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-02-13
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    d95206af-11bc-40fa-9173-ac997ea49ce8

    Device Description

    EON ORIG SPHERICAL #1 REG 500

    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
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    EJJ Alloy, Amalgam

    GMDN Terms

    Code Name
    34836 Dental amalgam alloy

    Identifiers

    Type ID
    Primary D74422905680

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    0 – 25 Degrees Celsius