PROSTHESIS 1156324 FISCH PISTON .4X6


Product Overview

PROSTHESIS 1156324 FISCH PISTON .4X6
Fisch - 1156324


Device Description

A sterile device intended to be implanted for the functional reconstruction of segments of the ossicular chain (mallues, incus, and/or stapes bones) to facilitate the conduction of sound waves from the tympanic membrane to the inner ear. It is designed to treat conductive hearing loss from traumatic or surgical injury, otosclerosis, congenital fixation of the stapes, or chronic middle ear disease. The device is typically in the form of a tube made of metal [e.g., stainless steel, titanium (Ti)], polymers, or a combination of these materials.


Environmental Conditions

No Data Available


Device Sizes

  • Shaft Length is 4.0 MM
  • Length: 6.0 Millimeter
  • Shaft Diameter is 0.4 MM
    • Shaft Length is 4.0 MM
    • Length: 6.0 Millimeter
    • Shaft Diameter is 0.4 MM


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: LTB

    Device Name: Cyclosporine Radioimmunoassay

    Device Class: 2

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 1

    Review Panel: TX

    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: 862.1235

    Third Party Flag: Y

    Medical Specialty: CH


    Device Identifiers

    Device Id: 00681490035538

    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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