BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    MedGyn Gynescope

    DI: M803010198 · Model: AL-401 · MEDGYN PRODUCTS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    MedGyn Gynescope
    Primary DI
    M803010198
    Version / Model
    AL-401
    Catalog Number
    010198
    Company Name
    MEDGYN PRODUCTS, INC.
    Labeler DUNS
    103913430
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-08
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    e4a9c5c5-50b5-4ca4-b2fb-056a84b67ea2

    Device Description

    MedGyn AL-401 Colposcope with Tilt Stand (3-Step Magnification)

    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
    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 M803010198