BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Premium Plus

    DI: D83810024NC4 · Model: 1002-4NC · Premium Plus International Limited
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Premium Plus
    Primary DI
    D83810024NC4
    Version / Model
    1002-4NC
    Company Name
    Premium Plus International Limited
    Labeler DUNS
    668367758
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-01-01
    Public Version
    1
    Public Version Date
    2019-02-01
    Public Version Status
    New
    Public Device Record Key
    40a7a47e-e160-4d62-bb0e-63fabf7b2dd2

    Device Description

    Dental prophy air motor, nose cone, dental handpiece

    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
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    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
    EFB Handpiece, Air-Powered, Dental

    GMDN Terms

    Code Name
    43698 Dental power tool system, pneumatic

    Identifiers

    Type ID
    Package D83810024NC8
    Package D83810024NC2
    Primary D83810024NC4

    Premarket Submissions

    Submission Number Supplement Number
    K170261 000