BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    FertiloScope

    DI: 05060508530046 · Model: FTO 1.40 · VIO HEALTHTECH LIMITED
    View on AccessGUDID
    Product Codes
    3
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    FertiloScope
    Primary DI
    05060508530046
    Version / Model
    FTO 1.40
    Company Name
    VIO HEALTHTECH LIMITED
    Labeler DUNS
    347449352
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-10-17
    Public Version
    5
    Public Version Date
    2023-01-31
    Public Version Status
    Update
    Public Device Record Key
    a0817c5c-2f65-4827-85ab-5fa32831afe5
    Distribution End Date
    2021-02-10

    Device Description

    Transvaginal Cannula with its pointed trocar, devised for introduction in the pouch of Douglas in order to perform a Transvaginal hydro-pelviscopy

    Device Characteristics

    Single Use
    Yes
    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
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Ethylene Oxide

    Product Codes

    Code Name
    HIH Hysteroscope (And Accessories)
    HEW Culdoscope (And Accessories)
    HET Laparoscope, Gynecologic (And Accessories)

    GMDN Terms

    Code Name
    42412 Laparoscopic access cannula, single-use

    Identifiers

    Type ID
    Primary 05060508530046