VENT TUBE 14351 5PK FLPL 1.14MM 12MM


Product Overview

VENT TUBE 14351 5PK FLPL 1.14MM 12MM
N/A - 14351


Device Description

A small, hollow cylinder intended to be implanted, by insertion through the tympanic membrane, for ventilation or drainage of the middle ear. Otherwise known as a myringotomy tube, grommet or an aural vent tube, it is made of materials such as polytetrafluoroethylene (PTFE), polyethylene (PE), silicon elastomer, or porous polyethylene. One type, known as the malleus clip tube, attaches to the malleus. Disposable devices associated with implantation may be included with the device, which may be used to implant bilateral tubes.


Environmental Conditions

No Data Available


Device Sizes

  • Length: 12.0 Millimeter
  • Lumen/Inner Diameter: 1.14 Millimeter
    • Length: 12.0 Millimeter
    • Lumen/Inner Diameter: 1.14 Millimeter


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: ETD

    Device Name: Tube, Tympanostomy

    Device Class: 2

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 1

    Review Panel: EN

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: N/A

    Life Sustain Support Flag: N

    Unclassified Reason: N/A

    Implant Flag: Y

    Target Area: N/A

    Regulation Number: 874.3880

    Third Party Flag: N

    Medical Specialty: EN


    Device Identifiers

    Device Id: 20763000039930

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 00763000039936

    Package Quantity: 5

    Package Discontinue Date: N/A

    Package Status: In Commercial Distribution

    Package Type: PK


    Device Id: 00763000039936

    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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