BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Gynescope, console system

    DI: 57290018240026 · Model: 01 · ILLUMIGYN LTD
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Gynescope, console system
    Primary DI
    57290018240026
    Version / Model
    01
    Catalog Number
    IL-100-100-100
    Company Name
    ILLUMIGYN LTD
    Labeler DUNS
    600627621
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-11-26
    Public Version
    2
    Public Version Date
    2022-10-24
    Public Version Status
    Update
    Public Device Record Key
    6451e6cf-7feb-454e-ab89-797e7bb88aa7

    Device Description

    Gynescope™ system console for image capturing and digital image archiving

    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
    MR Unsafe
    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
    Yes

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    HEX Colposcope (And Colpomicroscope)

    GMDN Terms

    Code Name
    64925 Video colposcope camera/display unit

    Identifiers

    Type ID
    Primary 57290018240026

    Premarket Submissions

    Submission Number Supplement Number
    K190187 000