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    FDA UDI In Commercial Distribution 🇺🇸 United States

    Dong-A Pharmaceutical Co., Ltd.

    DI: 08806011633242 · Model: Tempo Tampon Super · Dong-A Pharmaceutical Co., Ltd.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Dong-A Pharmaceutical Co., Ltd.
    Primary DI
    08806011633242
    Version / Model
    Tempo Tampon Super
    Company Name
    Dong-A Pharmaceutical Co., Ltd.
    Labeler DUNS
    688733015
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-02-14
    Public Version
    1
    Public Version Date
    2023-02-22
    Public Version Status
    New
    Public Device Record Key
    937923cd-8c1e-44d2-982a-2aa779eb0732

    Device Description

    The Tempo Tampon is intended for insertion into the vagina for the absorption of menstrual or other vaginal discharge.

    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
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    HEB Tampon, Menstrual, Unscented

    GMDN Terms

    Code Name
    35694 Menstrual tampon, unscented

    Identifiers

    Type ID
    Primary 08806011633242

    Premarket Submissions

    Submission Number Supplement Number
    K212277 000