Handpiece


Product Overview

Handpiece
TruClear - 7209807


Device Description

An assembly of devices used to mechanically cut (slice), core (cut a hole into), peel (remove surface), and extract selected tissue from the body (a process known as morcellation), typically during laparoscopic surgery (e.g., for tumour or fibroid removal). It typically consists of a handpiece (high-speed rotating blade and holder) for tissue resection and extraction, a mains electricity (AC-powered) control unit that drives the handpiece blade, a remote drive cable to connect the handpiece with the control unit, and a foot-switch; some designs may also provide suction intended for removal of resected tissue.


Environmental Conditions

  • Handling Environment Atmospheric Pressure - KiloPascal
    • 106.00
    • 70.00
  • Handling Environment Humidity - Percent (%) Relative Humidity
    • 70.00
    • 30.00
  • Handling Environment Temperature - Degrees Fahrenheit
    • 104.00
    • 50.00
  • Storage Environment Atmospheric Pressure - KiloPascal
    • 106.00
    • 50.00
  • Storage Environment Humidity - Percent (%) Relative Humidity
    • 90.00
    • 20.00
  • Storage Environment Temperature - Degrees Fahrenheit
    • 140.00
    • -4.00

  • 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: 10884521749924

    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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