BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    VarseoSmile Temp

    DI: EBGO41103US1 · Model: 41103US · BEGO Bremer Goldschlägerei Wilh. Herbst GmbH & Co.KG
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    VarseoSmile Temp
    Primary DI
    EBGO41103US1
    Version / Model
    41103US
    Catalog Number
    41103US
    Company Name
    BEGO Bremer Goldschlägerei Wilh. Herbst GmbH & Co.KG
    Labeler DUNS
    316483072
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-05-27
    Public Version
    3
    Public Version Date
    2021-10-29
    Public Version Status
    Update
    Public Device Record Key
    6f24032e-aab8-4cea-a0c8-a143c31f6733

    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
    EBG Crown And Bridge, Temporary, Resin

    GMDN Terms

    Code Name
    45236 Temporary dental crown/bridge resin

    Identifiers

    Type ID
    Primary EBGO41103US1
    Package EBGO41103US2

    Customer Contacts

    Phone
    +4942120280
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K193553 000

    Storage Conditions

    Type
    Special Storage Condition, Specify
    Special Conditions
    Dry