BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Rovers® Cervex-Brush® Combi

    DI: 08719189246070 · Model: 380101000 · Rovers Medical Devices B.V.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    25

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    Basic Information

    Brand Name
    Rovers® Cervex-Brush® Combi
    Primary DI
    08719189246070
    Version / Model
    380101000
    Company Name
    Rovers Medical Devices B.V.
    Labeler DUNS
    402155084
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    25
    Record Status
    Published
    Publish Date
    2018-07-16
    Public Version
    2
    Public Version Date
    2023-07-13
    Public Version Status
    Update
    Public Device Record Key
    fac67ca5-9eef-41ac-a9e2-41fca407573c

    Device Description

    Cervical cell sampler

    Device Characteristics

    Single Use
    Yes
    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
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    HHT Spatula, Cervical, Cytological

    GMDN Terms

    Code Name
    42537 Cytology scraper, single-use

    Identifiers

    Type ID
    Primary 08719189246070
    Unit of Use 08719189246063
    Package 18719189246077

    Customer Contacts

    Phone
    +31412648870
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K043369 000