BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Lamaze

    DI: B268Y5288L0 · Model: Y5228L · TOMY INTERNATIONAL, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    4
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Lamaze
    Primary DI
    B268Y5288L0
    Version / Model
    Y5228L
    Company Name
    TOMY INTERNATIONAL, INC.
    Labeler DUNS
    065183758
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-10-11
    Public Version
    1
    Public Version Date
    2019-10-21
    Public Version Status
    New
    Public Device Record Key
    9d1a10a5-8ae0-4ae9-8708-ee8dc2cabd4e

    Device Description

    Teether

    Device Characteristics

    Single Use
    No
    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
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    KKO Ring, Teething, Fluid-Filled

    GMDN Terms

    Code Name
    44272 Teething device, fluid-filled

    Identifiers

    Type ID
    Package B268Y5288L9
    Package B268Y5288L6
    Package B268Y5288L1
    Primary B268Y5288L0