BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Rovers® Anex® Brush

    DI: 18719189246015 · Model: 380090331 · 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® Anex® Brush
    Primary DI
    18719189246015
    Version / Model
    380090331
    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
    4385517b-e9ba-4645-bb1a-eaa5f9fbaaab

    Device Description

    The Anex® Brush is a single-use cell sampler intended to collect cells from the anal canal.

    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
    Yes
    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
    KXG Applicator, Absorbent Tipped, Sterile

    GMDN Terms

    Code Name
    42537 Cytology scraper, single-use

    Identifiers

    Type ID
    Package 08719189246544
    Primary 18719189246015
    Package 28719189246012
    Unit of Use 08719189246018