SHUNT 1156404 AUSTIN ENDOLYMPHATIC


Product Overview

SHUNT 1156404 AUSTIN ENDOLYMPHATIC
Austin - 1156404


Device Description

A sterile tube or sheet surgically implanted in the membranous labyrinth of the inner ear to drain excess endolymphatic fluid typically as treatment for Meniere's disease, an inner ear disorder. The device permits unrestricted flow of the fluid from the distended end of the endolymphatic system into the mastoid cavity where resorption occurs. It is typically made of silicone. This is a single-use device.


Environmental Conditions

No Data Available


Device Sizes

  • Chamber Diameter is 2.0 MM
  • Chamber Length is 3.5 MM
  • Length: 18.0 Millimeter
    • Chamber Diameter is 2.0 MM
    • Chamber Length is 3.5 MM
    • Length: 18.0 Millimeter


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: ESZ

    Device Name: Tube, Shunt, Endolymphatic

    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: 874.3820

    Third Party Flag: N

    Medical Specialty: EN


    Device Identifiers

    Device Id: 00681490035798

    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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