Proxis Ureteral Access Sheath


Product Overview

Proxis Ureteral Access Sheath
Proxis Ureteral Access Sheath - 231145


Device Description

A flexible tube intended to be used for ureteral access to allow introduction of other instruments (e.g., endoscope, catheter) and/or for guidewire exchange during a urological procedure. It may be intended for ureteral access via transurethral and/or percutaneous approach, and typically includes an inner dilator; it is however not a full introduction set. This is a single-use device.


Environmental Conditions

No Data Available


Device Sizes

  • Catheter Gauge: 13 French
  • Length: 45 Centimeter
    • Catheter Gauge: 13 French
    • Length: 45 Centimeter


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: FED

    Device Name: Endoscopic Access Overtube, Gastroenterology-Urology

    Device Class: 2

    Physical State: overtube

    Definition: To facilitate passage and aid advancement of endoscopes into the body, especially in cases of repeated intubation.

    Submission Type ID: 1

    Review Panel: GU

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: Endoscope inserted and advanced through center of device

    Life Sustain Support Flag: N

    Unclassified Reason: N/A

    Implant Flag: N

    Target Area: various openings in gi and gu tract

    Regulation Number: 876.1500

    Third Party Flag: N

    Medical Specialty: GU


    Device Identifiers

    Device Id: 00801741212765

    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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