GORE VIABIL Biliary Endoprosthesis

Basic Information

• Brand Name: GORE VIABIL Biliary Endoprosthesis
• Primary DI: 00733132615698
• Version / Model: VN1004040
• Catalog Number: VN1004040
• 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: 2016-03-07
• Public Version: 8
• Public Version Date: 2023-08-29
• Public Version Status: Update
• Public Device Record Key: 2393da25-25ce-4e28-8162-7b41a83476d2

Device Description

GORE VIABIL BILIARY ENDO 10mmX4cm 10Fr

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
FGE	Catheter, Biliary, Diagnostic	Gastroenterology, Urology	876.5010	2

GMDN Terms

Code	Name	Definition	Implantable	Status
43566	Polymer-metal biliary stent, non-bioabsorbable	A non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. It is a mesh structure made of metal which is covered/lined with a synthetic polymer material (e.g., silicone) that prevents lateral flow and tissue ingrowth and facilitates removability. It is typically expanded in situ (e.g., with a balloon catheter or self-expands) and disposable devices intended to assist implantation may be included.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00733132615698	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K041423	000
K081184	000

Device Sizes

Type	Value	Unit	Text
Catheter Gauge	10	French
Length	4	Centimeter
Lumen/Inner Diameter	10	Millimeter