Bard® E-LUMINEXX™ Vascular and Biliary Stent 8 mm x 80 mm (135 cm delivery catheter)

Bard® E
E-Luminexx® Vascular & Biliary Stent - ZBL08080

A non-bioabsorbable tubular device intended to be implanted in a peripheral artery (excludes aorta, coronary, and intracranial arteries) to indefinitely maintain patency and improve luminal diameter in patients with atherosclerotic disease, or following the recanalization of a total occlusion. It may additionally be intended to be implanted in an obstructed biliary duct; it is not dedicated to carotid artery implantation. The stent is made entirely of metal [e.g., nickel-titanium alloy (Nitinol) mesh structure] and is typically implanted by a dedicated instrument where it self-expands upon release or is balloon expanded.

• Implant Diameter,8 Millimeter
• Catheter Length,135 Centimeter
• Implant Length,80 Millimeter

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: NIO

Device Name: Stent, Iliac

Device Class: 3

Physical State: N/A

Definition: Stent, Iliac -- a metal scaffold placed via a delivery catheter into the iliac artery to maintain the lumen

Submission Type ID: 2

Review Panel: CV

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: N/A

Third Party Flag: N

Medical Specialty: N/A

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 Id: 04049519009155

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