The OMNI™Hysteroscope is used to provide viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures.


Product Overview

The OMNI™Hysteroscope is used to provide viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures.
30 Degree 3.7mm Diagnostic Sheath - 60-201-30


Device Description

An endoscope with a rigid inserted portion intended for the visual examination and treatment of the canal of the cervix and the uterine cavity (uterus). It is inserted through the vagina during hysteroscopy. Anatomical images are transmitted to the user through relayed lens optics or a fibreoptic bundle. Distention of the uterus with, e.g., carbon dioxide(CO2) gas may be used to improve viewing. This device is typically used to evaluate/treat fibroids (myomas), polyps, or causes of severe cramping (dysmenorrhea), heavy menstrual periods (menorrhagia), and bleeding between periods (metrorrhagia). This is a reusable device.


Environmental Conditions

  • Storage Environment Temperature - Degrees Celsius
    • 50.00
    • -29.00

  • Device Sizes

    No Data Available


    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: True

    Sterilization Methods:

  • Moist Heat or Steam Sterilization
    • Moist Heat or Steam Sterilization


    Product Codes

    Code: HIH

    Device Name: Hysteroscope (And Accessories)

    Device Class: 2

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 1

    Review Panel: OB

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: N/A

    Life Sustain Support Flag: N

    Unclassified Reason: N/A

    Implant Flag: N

    Target Area: N/A

    Regulation Number: 884.1690

    Third Party Flag: Y

    Medical Specialty: OB


    Device Identifiers

    Device Id: 15420045513624

    Device Type: Primary

    DeviceId Issuing Agency: GS1

    Contains DI Number: N/A

    Package Quantity: N/A

    Package Discontinue Date: N/A

    Package Status: N/A

    Package Type: N/A


    Device Id: 25420045513621

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 15420045513624

    Package Quantity: 1

    Package Discontinue Date: N/A

    Package Status: In Commercial Distribution

    Package Type: EACH


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