BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    myONE E99/53C

    DI: 00726893511422 · Model: MYONE-E99/53C-36 · GLOBAL PROTECTION CORP.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    36

    Basic Information

    Brand Name
    myONE E99/53C
    Primary DI
    00726893511422
    Version / Model
    MYONE-E99/53C-36
    Company Name
    GLOBAL PROTECTION CORP.
    Labeler DUNS
    364614362
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    36
    Record Status
    Published
    Publish Date
    2023-03-30
    Public Version
    2
    Public Version Date
    2023-10-31
    Public Version Status
    Update
    Public Device Record Key
    d887ae1b-eff8-4e8c-82ff-526e960e9e1c

    Device Description

    36 Lubricated Latex Condoms

    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
    Yes
    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 80726893511428
    Primary 00726893511422