BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Kernel

    DI: 06928798600407 · Model: KN-5000C · Xuzhou Kernel Medical Equipment Co., Ltd.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Kernel
    Primary DI
    06928798600407
    Version / Model
    KN-5000C
    Company Name
    Xuzhou Kernel Medical Equipment Co., Ltd.
    Labeler DUNS
    530873660
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-01-14
    Public Version
    1
    Public Version Date
    2021-01-22
    Public Version Status
    New
    Public Device Record Key
    89abd41f-6367-483e-9076-c6b0d2104895
    Distribution End Date
    2021-01-14

    Device Description

    The 308nm Excimer System is intended to be used for the treatment of psoriasis and vitiligo. It is to be used on intact skin only.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    MR Safe
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    Yes
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    FTC Light, Ultraviolet, Dermatological

    GMDN Terms

    Code Name
    62637 Hand-held ophthalmic ultraviolet phototherapy unit

    Identifiers

    Type ID
    Primary 06928798600407