STENT AB9U14100090 ABRE V01


Product Overview

STENT AB9U14100090 ABRE V01
Abre™ - AB9U14100090


Device Description

A non-bioabsorbable tubular device intended to be implanted in an iliac and/or femoral vein to maintain patency in patients with constrained venous outflow. It is inserted and advanced to the site of implantation with a dedicated catheter where it self-expands upon release. The device is typically made of nickel-titanium alloy (Nitinol) and has radiopaque marker(s) for visualization; it is available in a variety of diameters and lengths. Disposable devices associated with implantation may be included.


Environmental Conditions

  • Special Storage Condition, Specify
    • Avoid exposing the Abre system to water, sunlight, extreme temperatures, and high humidity during storage. Store the Abre system under controlled room temperature.
  • Special Storage Condition, Specify
    • Keep away from sunlight
  • Special Storage Condition, Specify
    • Keep dry

  • Device Sizes

  • Lumen Diameter 11.5 - 13.5 MM
  • Minimum Sheath 9FR
  • Stent Diameter 14 X 100 MM
  • Stent Length: 100.0 Millimeter
  • Working Length 90 CM
    • Lumen Diameter 11.5 - 13.5 MM
    • Minimum Sheath 9FR
    • Stent Diameter 14 X 100 MM
    • Stent Length: 100.0 Millimeter
    • Working Length 90 CM


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: QAN

    Device Name: Stent, Iliac Vein

    Device Class: 3

    Physical State: A metal scaffold placed via a delivery catheter

    Definition: A metal scaffold placed via a delivery catheter in the iliac vein to maintain the lumen

    Submission Type ID: 2

    Review Panel: CV

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: A metal scaffold placed via a delivery catheter in the iliac vein to maintain the lumen

    Life Sustain Support Flag: Y

    Unclassified Reason: N/A

    Implant Flag: Y

    Target Area: Iliac vein

    Regulation Number: N/A

    Third Party Flag: N

    Medical Specialty: N/A


    Device Identifiers

    Device Id: 00643169796300

    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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