BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Dental Instrument

    DI: 08800016110371 · Model: KIGH · Cowellmedi Co.,Ltd
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Dental Instrument
    Primary DI
    08800016110371
    Version / Model
    KIGH
    Company Name
    Cowellmedi Co.,Ltd
    Labeler DUNS
    688753763
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-08-09
    Public Version
    1
    Public Version Date
    2024-08-19
    Public Version Status
    New
    Public Device Record Key
    3dced355-06c0-4e2f-a548-a2c8cf97a46d

    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
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    DZN Instruments, Dental Hand

    GMDN Terms

    Code Name
    64304 Manual non-rotary dental instrument handle

    Identifiers

    Type ID
    Primary 08800016110371