Self-Expanding Biliary Stent System


Product Overview

Self
Protege GPS - SERB65-07-30-80


Device Description

A non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency; it is not intended for vascular implantation. It may be a mesh structure or a continuous tube and is made entirely of metal [e.g., high-grade stainless steel, cobalt-chrome (Co-Cr), nickel-titanium alloy (Nitinol)]. It may be expandable in situ (e.g., with a balloon catheter or self-expands) and disposable devices intended to assist implantation may be included.


Environmental Conditions

  • Special Storage Condition, Specify
    • Keep dry

  • Device Sizes

  • Outer Diameter: 7 Millimeter
  • Length: 30 Millimeter
  • Working Length,80,Centimeter;Compatible Guidewire,.035,Inch;Lumen Diameter,5.5-6.5,Millimeter;
  • Catheter Gauge: 6 French
    • Outer Diameter: 7 Millimeter
    • Length: 30 Millimeter
    • Working Length,80,Centimeter;Compatible Guidewire,.035,Inch;Lumen Diameter,5.5-6.5,Millimeter;
    • Catheter Gauge: 6 French


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: FGE

    Device Name: Stents, Drains And Dilators For The Biliary Ducts

    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: Y

    Unclassified Reason: N/A

    Implant Flag: Y

    Target Area: N/A

    Regulation Number: 876.5010

    Third Party Flag: N

    Medical Specialty: GU


    Device Identifiers

    Device Id: 00821684002537

    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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