OTIS URETHROTOME STRAIGHT W/3 GUIDE TIPS & 2 KNIFE BLADES IN CASE OVERALL LENGTH 11-3/4"(30CM)


Product Overview

OTIS URETHROTOME STRAIGHT W/3 GUIDE TIPS & 2 KNIFE BLADES IN CASE OVERALL LENGTH 11
V. Mueller - GU4140


Device Description

A surgical instrument designed like a long catheter or thin flexible endoscope shape with a lateral moveable small knife at the distal end which is used for incising strictures in the urethra, (the duct by which urine is discharged from the bladder). This operation may be performed either "blind", where the surgeon cannot see the site, or with the help of endoscopic instruments. Some device designs may incorporate an optical channel for endoscopic visual control. This is a reusable device.


Environmental Conditions

No Data Available


Device Sizes

No Data Available


Device Sterilization

Device Sterile: False

Sterilization Prior To Use: True

Sterilization Methods:

  • Moist Heat or Steam Sterilization
    • Moist Heat or Steam Sterilization


    Product Codes

    Code: EZO

    Device Name: Urethrotome

    Device Class: 2

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 4

    Review Panel: GU

    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: 876.4770

    Third Party Flag: N

    Medical Specialty: GU


    Device Identifiers

    Device Id: 10885403050046

    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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