BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Rovers® Cervex-Brush®

    DI: 87191892460016 · Model: 380100311 · Rovers Medical Devices B.V.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    50

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    Basic Information

    Brand Name
    Rovers® Cervex-Brush®
    Primary DI
    87191892460016
    Version / Model
    380100311
    Company Name
    Rovers Medical Devices B.V.
    Labeler DUNS
    402155084
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    50
    Record Status
    Published
    Publish Date
    2016-10-03
    Public Version
    4
    Public Version Date
    2019-09-12
    Public Version Status
    Update
    Public Device Record Key
    3966bb23-94be-4c1c-90b1-159b76bbc4d1
    Distribution End Date
    2018-08-01

    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 87191892460016
    Unit of Use 08719189246049

    Customer Contacts

    Phone
    +31412648870
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K930955 000