BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Bluephase 20i

    DI: DVIV613735BU1 · Model: 613735BU · IVOCLAR VIVADENT AKTIENGESELLSCHAFT
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Bluephase 20i
    Primary DI
    DVIV613735BU1
    Version / Model
    613735BU
    Catalog Number
    613735BU
    Company Name
    IVOCLAR VIVADENT AKTIENGESELLSCHAFT
    Labeler DUNS
    448015938
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-01-27
    Public Version
    1
    Public Version Date
    2021-02-04
    Public Version Status
    New
    Public Device Record Key
    78415784-75b0-4f90-a128-15ddf925e724
    Distribution End Date
    2021-01-28

    Device Description

    Bluephase 20i (G2)

    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
    EBZ ACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATION

    GMDN Terms

    Code Name
    35775 Dental/surgical polymerization lamp

    Identifiers

    Type ID
    Primary DVIV613735BU1