Totalis Flexible Endo Kit with InLay Optima® Ureteral Stent, SkyLite™ Tipless Stone Basket and Solo™ Plus Hybrid Guidewire


Product Overview

Totalis Flexible Endo Kit with InLay Optima® Ureteral Stent, SkyLite™ Tipless Stone Basket and Solo™ Plus Hybrid Guidewire
Totalis™ Flexible Endo Kit - FEK24HW


Device Description

A collection of devices intended to assist treatment of a blocked ureter and to help maintain ureteral patency through natural orifice or percutaneous access. It includes a polymeric ureteral stent, a device(s) intended to trap, retrieve, and/or manipulate urinary stones (e.g., urinary stone retrieval basket), and typically devices associated with access/stent-implantation (e.g., guidewire). This is a single-use device.


Environmental Conditions

No Data Available


Device Sizes

  • Length: 24 Centimeter
  • Catheter Gauge: 6 French
    • Length: 24 Centimeter
    • Catheter Gauge: 6 French


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: FAD

    Device Name: Stent, Ureteral

    Device Class: 2

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 1

    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: Y

    Target Area: N/A

    Regulation Number: 876.4620

    Third Party Flag: Y

    Medical Specialty: GU


    Device Identifiers

    Device Id: 00801741097607

    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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