PROSTHESIS 1156308 FISCH FOOTPLT SHOE


Product Overview

PROSTHESIS 1156308 FISCH FOOTPLT SHOE
Fisch - 1156308


Device Description

A sterile device intended to be implanted for the total functional reconstruction of the ossicular chain (mallues, incus, and 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 polymers.


Environmental Conditions

No Data Available


Device Sizes

  • Width is 0.8 MM
  • Length: 1.75 Millimeter
    • Width is 0.8 MM
    • Length: 1.75 Millimeter


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: LBM

    Device Name: Porous Polyethylene Ossicular Replacement

    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: 874.3450

    Third Party Flag: N

    Medical Specialty: EN


    Device Identifiers

    Device Id: 00681490035491

    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


    GMDN ®. © GMDN Agency 2005-2024.
    Educational Resources
    Videos