BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    AxioSil Heavy Body

    DI: D161260150 · Model: 26015 2 x 50ml Fast Set · Axiodent Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    AxioSil Heavy Body
    Primary DI
    D161260150
    Version / Model
    26015 2 x 50ml Fast Set
    Company Name
    Axiodent Inc.
    Labeler DUNS
    119330625
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-10-04
    Public Version
    1
    Public Version Date
    2024-10-14
    Public Version Status
    New
    Public Device Record Key
    a25611bf-0117-4ee6-b52b-3776974263f9

    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
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    ELW Material, Impression

    GMDN Terms

    Code Name
    34799 Composite dental impression material

    Identifiers

    Type ID
    Primary D161260150