BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    PROPHYflex 4 S Lime

    DI: EKAV300459300 · Model: 3.004.5930 · KaVo Dental GmbH
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    PROPHYflex 4 S Lime
    Primary DI
    EKAV300459300
    Version / Model
    3.004.5930
    Catalog Number
    4 S Lime
    Company Name
    KaVo Dental GmbH
    Labeler DUNS
    333710619
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-03-04
    Public Version
    3
    Public Version Date
    2021-11-08
    Public Version Status
    Update
    Public Device Record Key
    2dcf95e4-62e2-43c1-a4b7-92566140ebc4

    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
    Yes
    Sterilization Methods
    Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    EJR AGENT, POLISHING, ABRASIVE, ORAL CAVITY

    GMDN Terms

    Code Name
    45406 Dental abrasive air jet system handpiece

    Identifiers

    Type ID
    Primary EKAV300459300

    Customer Contacts

    Phone
    +18475506800
    Email
    [email protected]

    Storage Conditions

    Type
    Handling Environment Temperature
    Temperature Range
    -20 – 70 Degrees Celsius