BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Rovers® Cervex-Brush®

    DI: 18719189246268 · Model: 380100431 · Rovers Medical Devices B.V.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    4
    Pkg Device Count
    100

    Basic Information

    Brand Name
    Rovers® Cervex-Brush®
    Primary DI
    18719189246268
    Version / Model
    380100431
    Company Name
    Rovers Medical Devices B.V.
    Labeler DUNS
    402155084
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    100
    Record Status
    Published
    Publish Date
    2023-07-12
    Public Version
    1
    Public Version Date
    2023-07-20
    Public Version Status
    New
    Public Device Record Key
    4e8abeaa-b7bd-4706-8079-3b8148fc9ab4

    Device Description

    The Cervex-Brush® is a single-use cell sampler intended to collect simultaneous cell material from the cervical os, ectocervical and endo-cervical in women.

    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
    No
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    HHT Spatula, Cervical, Cytological

    GMDN Terms

    Code Name
    42537 Cytology scraper, single-use

    Identifiers

    Type ID
    Unit of Use 08719189246261
    Primary 18719189246268
    Package 28719189246265
    Package 08719189246414

    Premarket Submissions

    Submission Number Supplement Number
    K930955 000