V-Shaped Retractor


Product Overview

V
Laparofan - OMSLF10


Device Description

An assembly of mechanical devices intended to be used to create a space in the abdominal cavity for laparoscopic procedures by externally lifting the abdominal wall. This isobaric method of lifting the abdominal wall includes the insertion of a retractor, sling, subcutaneous wires or needles and an external lifting mechanism consisting of, e.g., a manual traction device, a support arm clamped to the operating table, or a winch and framework. This device requires no, or minimal, gas insufflation. This is a reusable device.


Environmental Conditions

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

  • Device Sizes

  • Length: 10 Centimeter
    • Length: 10 Centimeter


    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: 20884521067896

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 10884521067899

    Package Quantity: 5

    Package Discontinue Date: 9/24/2016 12:00:00 AM

    Package Status: Not in Commercial Distribution

    Package Type: CASE


    Device Id: 10884521067899

    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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