GORE VIABAHN VBX Balloon Expandable Endo

Basic Information

• Brand Name: GORE VIABAHN VBX Balloon Expandable Endo
• Primary DI: 00733132637546
• Version / Model: BXA082901A
• Catalog Number: BXA082901A
• 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: 2017-01-31
• Public Version: 10
• Public Version Date: 2023-08-29
• Public Version Status: Update
• Public Device Record Key: 5141e14f-0d41-4e45-af98-bb0c74b71833

Device Description

VIABAHN BX BALLOON EXP ENDO 8mmX29mm 7Fr 80cmCath Heparin

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: Yes
• 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
PRL	Iliac Covered Stent, Arterial	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
66619	Peripheral artery endovascular stent-graft, drug-coated	A non-bioabsorbable tubular device intended to be implanted in a peripheral artery (excludes coronary and intracranial arteries) to maintain patency and improve luminal diameter, and that includes a heparin coating intended to prevent thrombotic vessel re-narrowing; it may in addition be intended for optional implantation in the common iliac arteries which extends beyond the aortic bifurcation, or for venous implantation. It is comprised of a metallic outer mesh-like structure with an inner synthetic polymer tube (endovascular graft). It is percutaneously inserted to the site of implantation with a disposable delivery device which may be included with the stent-graft.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00733132637546	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P160021	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Catheter Working Length: 80 CM
Catheter Gauge	7	French
Outer Diameter	8	Millimeter
Length	29	Millimeter