BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Oi

    DI: 09421904034495 · Model: BCT Regular · ORGANIC INITIATIVE CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    5
    Pkg Device Count
    16

    Basic Information

    Brand Name
    Oi
    Primary DI
    09421904034495
    Version / Model
    BCT Regular
    Company Name
    ORGANIC INITIATIVE CORPORATION
    Labeler DUNS
    081157098
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    16
    Record Status
    Published
    Publish Date
    2023-12-20
    Public Version
    1
    Public Version Date
    2023-12-28
    Public Version Status
    New
    Public Device Record Key
    5373deb9-5bb2-40b1-b868-a02f114e36f7

    Device Description

    Oi Organic Cotton Tampons with BioCompact Applicator, Regular 16s

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    Yes
    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
    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
    Package 09421904034525
    Primary 09421904034495
    Package 09421034090255
    Package 09421034090002
    Unit of Use 09421034093324