BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Trojan Variety Pack BareSkin

    DI: 00022600999652 · Model: 00022600999652 · CHURCH & DWIGHT CO., INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    24

    Basic Information

    Brand Name
    Trojan Variety Pack BareSkin
    Primary DI
    00022600999652
    Version / Model
    00022600999652
    Company Name
    CHURCH & DWIGHT CO., INC.
    Labeler DUNS
    001211952
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    24
    Record Status
    Published
    Publish Date
    2021-04-30
    Public Version
    1
    Public Version Date
    2021-05-10
    Public Version Status
    New
    Public Device Record Key
    82afbc77-5555-4166-ad5b-a1dc4c7469ae

    Device Description

    For Contraception Plus STI Protection

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    Yes
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    Yes
    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
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    HIS Condom

    GMDN Terms

    Code Name
    45138 Basic male condom, Hevea-latex

    Identifiers

    Type ID
    Unit of Use 80022600999658
    Primary 00022600999652

    Premarket Submissions

    Submission Number Supplement Number
    K090259 000
    K141256 000
    K192669 000