Calibration Insert


Product Overview

Calibration Insert
TruClear - 72203506


Device Description

A mains electricity (AC-powered) device assembly used during endoscopic procedures of the uterus (i.e., hysteroscopy) to distend (expand by pressure) the uterus by filling the uterine cavity with a liquid to improve visualization (e.g., a hysteroscope) and enlarge the surgical field; it also circulates the fluid to provide irrigation that will remove tissue/debris from the site. This system will typically electronically monitor the volume differential between the irrigation fluid flowing into and out of the uterus. Some distention systems are combined with gynaecologic resectoscopes.


Environmental Conditions

No Data Available


Device Sizes

  • Length: 2.9 Millimeter
    • Length: 2.9 Millimeter


    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: 10884521744134

    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


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