INLAY URETERAL STENT w/o GUIDEWIRE


Product Overview

INLAY URETERAL STENT w/o GUIDEWIRE
Bard® InLay® Ureteral Stent - 778728


Device Description

A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed ureter (e.g., from stone, stricture, compression, fibrosis, trauma) to maintain luminal patency allowing urine to drain from the renal pelvis to the bladder. It is made of a synthetic polymer(s) [e.g., polytetrafluoroethylene (PTFE), polyethylene (PE), silicone], sometimes with a hydrophilic coating (e.g., hydrogel), and may have various designs (e.g., continuous tube with or without drainage side holes, covered or non-covered mesh structure). Disposable devices intended to assist implantation may be included. The device is typically intended for long-term, but not permanent, implantation.


Environmental Conditions

No Data Available


Device Sizes

  • Length: 28 Centimeter
  • Catheter Gauge: 7 French
    • Length: 28 Centimeter
    • Catheter Gauge: 7 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: 00801741014918

    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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