BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    HSG Kits

    DI: M803TMI1198 · Model: HSG tray with Shapeable 5F HS · 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
    HSG Kits
    Primary DI
    M803TMI1198
    Version / Model
    HSG tray with Shapeable 5F HS
    Catalog Number
    TMI1198
    Company Name
    MEDGYN PRODUCTS, INC.
    Labeler DUNS
    103913430
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-06-17
    Public Version
    1
    Public Version Date
    2022-06-27
    Public Version Status
    New
    Public Device Record Key
    69bfe4c6-73f1-45bf-b73e-356c8fc2dffa

    Device Description

    HSG tray with Shapeable 5F HS

    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
    LKF Cannula, Manipulator/Injector, Uterine

    GMDN Terms

    Code Name
    15622 Uterine injector

    Identifiers

    Type ID
    Primary M803TMI1198

    Premarket Submissions

    Submission Number Supplement Number
    K032835 000