BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    FEMTEX

    DI: 00748364102007 · Model: FT11812SO · FIRST QUALITY HYGIENIC, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    18

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    Basic Information

    Brand Name
    FEMTEX
    Primary DI
    00748364102007
    Version / Model
    FT11812SO
    Company Name
    FIRST QUALITY HYGIENIC, INC.
    Labeler DUNS
    806731840
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    18
    Record Status
    Published
    Publish Date
    2016-08-19
    Public Version
    5
    Public Version Date
    2022-06-10
    Public Version Status
    Update
    Public Device Record Key
    4f3a376d-5752-4c7b-bdf4-e5e5341ea6b4

    Device Description

    regular scented plastic applicator tampons

    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
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    HIL Tampon, Menstrual, Scented, Deodorized

    GMDN Terms

    Code Name
    32683 Menstrual tampon, scented

    Identifiers

    Type ID
    Primary 00748364102007
    Unit of Use 00074836410203

    Premarket Submissions

    Submission Number Supplement Number
    K050067 000