Devices & Diagnostics > Device

IMPLANT S0521-01 MAGNETIC STER MRI UNSAF


by MEDTRONIC XOMED, INC.
Product Overview

IMPLANT S0521
Otomag™ Alpha (M) Magnetic Implant - S0521-01


Device Description

A sterile implantable magnetized device intended to be used to magnetically hold in place a head-worn bone-conduction hearing aid (against the skin on the side of the head), usually using a base plate. It is metallic, typically flat-disc- or dual-disc-shaped, and permanently implanted with screws in the mastoid process or parietal bone of the skull. Disposable devices associated with implantation may be included.


Environmental Conditions

  • Storage Environment Temperature - Degrees Celsius
    • 50.00
    • -20.00


    • Device Sizes

    No Data Available


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: LXB

    Device Name: Hearing Aid, Bone Conduction

    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: N

    Target Area: N/A

    Regulation Number: 874.3302

    Third Party Flag: Y

    Medical Specialty: EN


    Device Identifiers

    Device Id: 00643169644632

    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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