- Physicians Office Resource

STENT AB9U18120090 ABRE V01
Abre™ - AB9U18120090

Device Description

A non-bioabsorbable, tubular device made of metal intended to be implanted in a peripheral (typically the iliac and/or femoral) vein to maintain patency in patients with constrained venous outflow; it is not intended for coronary or intracranial venous stenting. It is inserted and advanced to the site of implantation with a dedicated catheter where it self-expands upon release. It 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

Minimum Sheath 9FR

Stent Length: 120.0 Millimeter

Lumen Diameter 15.5 - 17.5 MM

Stent Diameter 18 X 120 MM

Working Length 90 CM

Minimum Sheath 9FR
Stent Length: 120.0 Millimeter
Lumen Diameter 15.5 - 17.5 MM
Stent Diameter 18 X 120 MM
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: 00643169796416

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

GMDN® is a registered trademark of The GMDN Agency. All rights reserved. The information provided on this site includes data supplied by The GMDN Agency ("GMDN Content"), which is used under licence from The GMDN Agency. Any data/information suppliers who wish to extract GMDN Content from this site in order to use it as a basis for creating and supporting commercial services such as alternative categorisation, alternative GMDN Term assignment, mapping to other categorisations or ontologies, or for AI training purposes, must first obtain an appropriate licence from The GMDN Agency. No such activity is permitted without a licence. For more information on obtaining a licence, please contact The GMDN Agency (https://www.gmdnagency.org/contact-us/). None of the GMDN content constitutes any endorsement, advice, representation or warranty about any specific medical devices that may be described by such content; and no representation or warranty is made in relation to instructions for use, suitability for any application, treatment or condition, regulatory status, or any properties of a particular medical device.