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    FDA UDI In Commercial Distribution 🇺🇸 United States

    MedGyn Laminaria

    DI: M803021023 · Model: size 3 with button · 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 Laminaria
    Primary DI
    M803021023
    Version / Model
    size 3 with button
    Catalog Number
    021023
    Company Name
    MEDGYN PRODUCTS, INC.
    Labeler DUNS
    103913430
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-08-29
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    54ba4447-a7e1-403f-be52-87e64ec74e0d

    Device Description

    Dilator of Uterine Cervix

    Device Characteristics

    Single Use
    Yes
    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
    MR Safe
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    HDY Dilator, Cervical, Hygroscopic-Laminaria

    GMDN Terms

    Code Name
    34965 Hygroscopic cervical dilator

    Identifiers

    Type ID
    Primary M803021023