BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Evogue Dental Unit

    DI: 04952195257577 · Model: Evogue Dental Unit · TAKARA BELMONT CORP.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Evogue Dental Unit
    Primary DI
    04952195257577
    Version / Model
    Evogue Dental Unit
    Catalog Number
    AU-HV3000D
    Company Name
    TAKARA BELMONT CORP.
    Labeler DUNS
    690540349
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-11-02
    Public Version
    3
    Public Version Date
    2023-08-02
    Public Version Status
    Update
    Public Device Record Key
    728ad90d-180b-4086-ab07-d3fa63f87059

    Device Description

    Evogue Dental Unit DR TABLE PMU OVERARM

    Device Characteristics

    Single Use
    No
    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
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    EIA Unit, Operative Dental

    GMDN Terms

    Code Name
    34991 Dental delivery system

    Identifiers

    Type ID
    Primary 04952195257577

    Customer Contacts

    Phone
    732 4695000
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K152100 000