PROSTHESIS 0341 ROBINSON MALL/OVAL 5MM


Product Overview

PROSTHESIS 0341 ROBINSON MALL/OVAL 5MM
Robinson - 0341


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

  • Shaft Diameter is 0.6 MM
  • Length: 5.0 Millimeter
    • Shaft Diameter is 0.6 MM
    • Length: 5.0 Millimeter


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: ETA

    Device Name: Replacement, Ossicular Prosthesis, Total

    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: 874.3495

    Third Party Flag: N

    Medical Specialty: EN


    Device Identifiers

    Device Id: 00681490017800

    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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