BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    NA

    DI: 04582275250428 · Model: Cellchek · KONAN MEDICAL, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    NA
    Primary DI
    04582275250428
    Version / Model
    Cellchek
    Company Name
    KONAN MEDICAL, INC.
    Labeler DUNS
    690768619
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-23
    Public Version
    6
    Public Version Date
    2020-02-07
    Public Version Status
    Update
    Public Device Record Key
    b4353428-edb3-497c-8ad3-3639f5a42463
    Distribution End Date
    2019-12-31

    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
    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
    NFJ System, image management, ophthalmic

    GMDN Terms

    Code Name
    45724 Eye anterior segment analyser software

    Identifiers

    Type ID
    Primary 04582275250428