BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Premium Plus

    DI: D838300BC4 · Model: 300BC · Premium Plus International Limited
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    4
    Pkg Device Count
    100

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    Basic Information

    Brand Name
    Premium Plus
    Primary DI
    D838300BC4
    Version / Model
    300BC
    Company Name
    Premium Plus International Limited
    Labeler DUNS
    668367758
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    100
    Record Status
    Published
    Publish Date
    2019-05-19
    Public Version
    1
    Public Version Date
    2019-05-27
    Public Version Status
    New
    Public Device Record Key
    b5939237-783f-4a9d-8c4f-41855e4b1a9b

    Device Description

    Dental saliva ejectors

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    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
    Yes
    PM Exempt
    Yes
    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
    No

    Product Codes

    Code Name
    DYN Mouthpiece, Saliva Ejector

    GMDN Terms

    Code Name
    37434 Dental suction system cannula, single-use

    Identifiers

    Type ID
    Primary D838300BC4
    Package D838300BC6
    Package D838300BC8
    Unit of Use D838300BC0