GORE® VIABAHN® FORTEGRA Venous Stent

Basic Information

• Brand Name: GORE® VIABAHN® FORTEGRA Venous Stent
• Primary DI: 00733132663941
• Version / Model: VNS121002A
• Catalog Number: VNS121002A
• Company Name: W. L. Gore & Associates, Inc.
• Labeler DUNS: 967358115
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-01-08
• Public Version: 1
• Public Version Date: 2026-01-16
• Public Version Status: New
• Public Device Record Key: 890d21ce-6617-4816-8d48-147f4491341c

Device Description

FORTEGRA VENOUS STENT 12mm x 100mm

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QTL	Stent, Vena Cava

GMDN Terms

Code	Name	Definition	Implantable	Status
67398	Polymer-coated central/peripheral venous stent	A tubular, mesh structure, consisting of a metal frame coated with a non-bioabsorbable synthetic polymer, designed to be implanted in a central and/or peripheral vein (e.g., inferior vena cava, iliofemoral vein) to improve blood flow in patients with symptomatic venous outflow obstruction; it is not intended for coronary or intracranial venous stenting. It is intended to provide biocompatibility while leaving pores (holes) to allow cross-luminal (lateral) blood flow (i.e., not a stent-graft). It is typically expanded in situ; disposable devices associated with implantation may be included with the stent.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00733132663941	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
P250017	000

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius