BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Galileo Colposcope, Direct Access

    DI: GYNX200LDAR0 · Model: 200LDA-R · GYNEX CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Galileo Colposcope, Direct Access
    Primary DI
    GYNX200LDAR0
    Version / Model
    200LDA-R
    Company Name
    GYNEX CORPORATION
    Labeler DUNS
    012997685
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-10-05
    Public Version
    3
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    4da50ffa-a535-4dc2-98fc-823c0177e831

    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
    Yes
    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
    HEX Colposcope (And Colpomicroscope)

    GMDN Terms

    Code Name
    10960 Colposcope

    Identifiers

    Type ID
    Primary GYNX200LDAR0

    Premarket Submissions

    Submission Number Supplement Number
    K061306 000