BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    KEN OKUYAMA

    DI: 04549930098016 · Model: KO-402-4 · SUNREEVE CO.,LTD.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    KEN OKUYAMA
    Primary DI
    04549930098016
    Version / Model
    KO-402-4
    Company Name
    SUNREEVE CO.,LTD.
    Labeler DUNS
    690695630
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-06-23
    Public Version
    1
    Public Version Date
    2022-07-01
    Public Version Status
    New
    Public Device Record Key
    0262817f-5cb3-4a4a-9614-7a238c34cea8

    Device Description

    An ophthalmic device designed to hold a pair of spectacle lenses in front of and close to the eyes of the user. It typically consists of a plastic or metallic frame that is supported by the nose and ears.

    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
    Yes
    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
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    HQZ Frame, Spectacle

    GMDN Terms

    Code Name
    32816 Spectacle frame

    Identifiers

    Type ID
    Primary 04549930098016