PERFORATOR 3155625 OTO-FLEX .5MM


Product Overview

PERFORATOR 3155625 OTO
Oto-Flex - 3155625


Device Description

A small rotary shaft of hard metal (e.g., steel) or carbide, with fluting or cutting planes of various shapes at the working end, designed for incising or removing cartilage and/or bone from the ear, nose, or throat during an ear/nose/throat (ENT) procedure. It is usually power-driven by a rotary handpiece or other powered device. It is typically used in mastoid surgery, frontal sinus surgery, or surgery of the facial nerves. This is a reusable device.


Environmental Conditions

No Data Available


Device Sizes

  • Outer Diameter: 0.5 Millimeter
    • Outer Diameter: 0.5 Millimeter


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: True

    Sterilization Methods:

  • Ethylene Oxide
  • Moist Heat or Steam Sterilization
    • Ethylene Oxide
    • Moist Heat or Steam Sterilization


    Product Codes

    Code: EQJ

    Device Name: Bur, Ear, Nose And Throat

    Device Class: 1

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 4

    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: 874.4140

    Third Party Flag: N

    Medical Specialty: EN


    Code: ERL

    Device Name: Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece

    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: 874.4250

    Third Party Flag: Y

    Medical Specialty: EN


    Device Identifiers

    Device Id: 00763000035907

    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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