MAJ-1072 R/L KNOB ATTACHMENT 140 SERIES


Product Overview

MAJ
RIGHT/LEFT ANGULATION KNOB ATTACHMENT - MAJ-1072


Device Description

A hand-held manual (non-electronic) attachment in the form of a large, easy-grip knob intended to be attached to the manual control of a medical device (e.g., endoscope) to assist a healthcare professional to operate the device. This is a reusable device.


Environmental Conditions

No Data Available


Device Sizes

No Data Available


Device Sterilization

Device Sterile: False

Sterilization Prior To Use: True

Sterilization Methods:

  • Ethylene Oxide
  • Moist Heat or Steam Sterilization
  • High-level Disinfectant
    • Ethylene Oxide
    • Moist Heat or Steam Sterilization
    • High-level Disinfectant


    Product Codes

    Code: FET

    Device Name: Endoscopic Video Imaging System/Component, Gastroenterology-Urology

    Device Class: 2

    Physical State: May include: ccd camera, monitor, other software or hardware associated with video equiptment, and components from other regulations, such as a pump.

    Definition: To allow for visualization of body cavities through an endoscope by projecting images to a monitor.

    Submission Type ID: 1

    Review Panel: GU

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: Inserted through endoscope.

    Life Sustain Support Flag: N

    Unclassified Reason: N/A

    Implant Flag: N

    Target Area: various body cavities, hollow organs, and canals in gi and gu tract.

    Regulation Number: 876.1500

    Third Party Flag: N

    Medical Specialty: GU


    Device Identifiers

    Device Id: 04953170150852

    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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