Lifestent® Biliary Stent, 9mm x 80mm (80cm catheter length)


Product Overview

Lifestent® Biliary Stent, 9mm x 80mm (80cm catheter length)
LifeStent® Biliary Stent - EX090801CD


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 Away from Sunlight
  • Special Storage Condition, Specify
    • Keep Dry

  • Device Sizes

  • Catheter Length, 80 Centimeter
  • Stent Length, 80 Millimeter
  • Inner Diameter, 9 Millimeter
    • Catheter Length, 80 Centimeter
    • Stent Length, 80 Millimeter
    • Inner Diameter, 9 Millimeter


    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: 04049519000510

    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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