Trocar Sleeve


Product Overview

Trocar Sleeve
Versaport Plus - 177995P


Device Description

A sterile sleeve assembly made of plastic materials intended to retract a small abdominal incision to allow multiple laparoscopic instruments to pass into the abdomen at the same time during a laparoscopic procedure. It will typically have an introducer that creates the abdominal incision (but is not used in cases where the surgeon chooses to make the incision), and a valve component that maintains the pneumoperitoneum established for the surgical procedure. It allows for the introduction of multiple instruments and/or a camera port, and removal of larger specimens during minimally-invasive laparoscopic surgery. This is a single-use device.


Environmental Conditions

  • Handling Environment Temperature - Degrees Fahrenheit
    • 130.00
    • N/A

  • Device Sizes

  • Outer Diameter: 12 Millimeter
  • Outer Diameter: 5 Millimeter
    • Outer Diameter: 12 Millimeter
    • Outer Diameter: 5 Millimeter


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: GCJ

    Device Name: Laparoscope, General & Plastic Surgery

    Device Class: 2

    Physical State: N/A

    Definition: Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

    Submission Type ID: 1

    Review Panel: SU

    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: 876.1500

    Third Party Flag: N

    Medical Specialty: GU


    Device Identifiers

    Device Id: 10884521094505

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 20884521094502

    Package Quantity: 3

    Package Discontinue Date: N/A

    Package Status: In Commercial Distribution

    Package Type: CASE


    Device Id: 20884521094502

    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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