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    FDA UDI In Commercial Distribution 🇺🇸 United States

    Puritan Histobrush®

    DI: 00609576325045 · Model: 25-2188 · Puritan Medical Products
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Puritan Histobrush®
    Primary DI
    00609576325045
    Version / Model
    25-2188
    Catalog Number
    25-2188
    Company Name
    Puritan Medical Products
    Labeler DUNS
    001101419
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-07
    Public Version
    4
    Public Version Date
    2020-08-26
    Public Version Status
    Update
    Public Device Record Key
    a7f645c9-8547-4504-be12-715e97ee4d25

    Device Description

    Histobrush 8” Sterile Soft Tapered Nylon Bristles Cytology Brush w/Polystyrene Handle - 25-2188

    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
    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
    Primary 00609576325045

    Premarket Submissions

    Submission Number Supplement Number
    K111681 000