GORE VIABIL Biliary Endoprosthesis VN0810040

GUDID 00733132615650

W. L. Gore & Associates, Inc.

Polymer-metal biliary stent Polymer-metal biliary stent Polymer-metal biliary stent Polymer-metal biliary stent Polymer-metal biliary stent Polymer-metal biliary stent Polymer-metal biliary stent Polymer-metal biliary stent Polymer-metal biliary stent Polymer-metal biliary stent Polymer-metal biliary stent Polymer-metal biliary stent Polymer-metal biliary stent Polymer-metal biliary stent Polymer-metal biliary stent Polymer-metal biliary stent Polymer-metal biliary stent, non-bioabsorbable Polymer-metal biliary stent, non-bioabsorbable Polymer-metal biliary stent, non-bioabsorbable Polymer-metal biliary stent, non-bioabsorbable Polymer-metal biliary stent, non-bioabsorbable Polymer-metal biliary stent, non-bioabsorbable Polymer-metal biliary stent, non-bioabsorbable Polymer-metal biliary stent, non-bioabsorbable Polymer-metal biliary stent, non-bioabsorbable Polymer-metal biliary stent, non-bioabsorbable Polymer-metal biliary stent, non-bioabsorbable Polymer-metal biliary stent, non-bioabsorbable Polymer-metal biliary stent, non-bioabsorbable Polymer-metal biliary stent, non-bioabsorbable Polymer-metal biliary stent, non-bioabsorbable Polymer-metal biliary stent, non-bioabsorbable Polymer-metal biliary stent, non-bioabsorbable Polymer-metal biliary stent, non-bioabsorbable Polymer-metal biliary stent, non-bioabsorbable Polymer-metal biliary stent, non-bioabsorbable Polymer-metal biliary stent, non-bioabsorbable Polymer-metal biliary stent, non-bioabsorbable Polymer-metal biliary stent, non-bioabsorbable Polymer-metal biliary stent, non-bioabsorbable Polymer-metal biliary stent, non-bioabsorbable Polymer-metal biliary stent, non-bioabsorbable Polymer-metal biliary stent, non-bioabsorbable Polymer-metal biliary stent, non-bioabsorbable Polymer-metal biliary stent, non-bioabsorbable Polymer-metal biliary stent, non-bioabsorbable Polymer-metal biliary stent, non-bioabsorbable Polymer-metal biliary stent, non-bioabsorbable Polymer-metal biliary stent, non-bioabsorbable Polymer-metal biliary stent, non-bioabsorbable Polymer-metal biliary stent, non-bioabsorbable Polymer-metal biliary stent, non-bioabsorbable Polymer-metal biliary stent, non-bioabsorbable Polymer-metal biliary stent, non-bioabsorbable Polymer-metal biliary stent, non-bioabsorbable Polymer-metal biliary stent, non-bioabsorbable Polymer-metal biliary stent, non-bioabsorbable Polymer-metal biliary stent, non-bioabsorbable Polymer-metal biliary stent, non-bioabsorbable Polymer-metal biliary stent, non-bioabsorbable Polymer-metal biliary stent, non-bioabsorbable Polymer-metal biliary stent, non-bioabsorbable Polymer-metal biliary stent, non-bioabsorbable Polymer-metal biliary stent, non-bioabsorbable Polymer-metal biliary stent, non-bioabsorbable Polymer-metal biliary stent, non-bioabsorbable

• Primary Device ID: 00733132615650
• NIH Device Record Key: ece8e5ee-3afb-49d0-b580-d4e447e2688b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GORE VIABIL Biliary Endoprosthesis
• Version Model Number: VN0810040
• Catalog Number: VN0810040
• Company DUNS: 967358115
• Company Name: W. L. Gore & Associates, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com

Device Dimensions

• Lumen/Inner Diameter: 8 Millimeter
• Lumen/Inner Diameter: 8 Millimeter
• Lumen/Inner Diameter: 8 Millimeter
• Lumen/Inner Diameter: 8 Millimeter
• Lumen/Inner Diameter: 8 Millimeter
• Lumen/Inner Diameter: 8 Millimeter
• Catheter Gauge: 10 French
• Length: 10 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Catheter Gauge: 10 French
• Length: 10 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Catheter Gauge: 10 French
• Length: 10 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Catheter Gauge: 10 French
• Length: 10 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Catheter Gauge: 10 French
• Length: 10 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Catheter Gauge: 10 French
• Length: 10 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Catheter Gauge: 10 French
• Length: 10 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Catheter Gauge: 10 French
• Length: 10 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Catheter Gauge: 10 French
• Length: 10 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Catheter Gauge: 10 French
• Length: 10 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Catheter Gauge: 10 French
• Length: 10 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Catheter Gauge: 10 French
• Length: 10 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Catheter Gauge: 10 French
• Length: 10 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Catheter Gauge: 10 French
• Length: 10 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Catheter Gauge: 10 French
• Length: 10 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Catheter Gauge: 10 French
• Length: 10 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Catheter Gauge: 10 French
• Length: 10 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Catheter Gauge: 10 French
• Length: 10 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Catheter Gauge: 10 French
• Length: 10 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Catheter Gauge: 10 French
• Length: 10 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Catheter Gauge: 10 French
• Length: 10 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Catheter Gauge: 10 French
• Length: 10 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Catheter Gauge: 10 French
• Length: 10 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Catheter Gauge: 10 French
• Length: 10 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Catheter Gauge: 10 French
• Length: 10 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Catheter Gauge: 10 French
• Length: 10 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Catheter Gauge: 10 French
• Length: 10 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Catheter Gauge: 10 French
• Length: 10 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Catheter Gauge: 10 French
• Length: 10 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Catheter Gauge: 10 French
• Length: 10 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Catheter Gauge: 10 French
• Length: 10 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Catheter Gauge: 10 French
• Length: 10 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Catheter Gauge: 10 French
• Length: 10 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Catheter Gauge: 10 French
• Length: 10 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Catheter Gauge: 10 French
• Length: 10 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Catheter Gauge: 10 French
• Length: 10 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Catheter Gauge: 10 French
• Length: 10 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Catheter Gauge: 10 French
• Length: 10 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Catheter Gauge: 10 French
• Length: 10 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Catheter Gauge: 10 French
• Length: 10 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Catheter Gauge: 10 French
• Length: 10 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Catheter Gauge: 10 French
• Length: 10 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Catheter Gauge: 10 French
• Length: 10 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Catheter Gauge: 10 French
• Length: 10 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Catheter Gauge: 10 French
• Length: 10 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Catheter Gauge: 10 French
• Length: 10 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Catheter Gauge: 10 French
• Length: 10 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Catheter Gauge: 10 French
• Length: 10 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Catheter Gauge: 10 French
• Length: 10 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Catheter Gauge: 10 French
• Length: 10 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Catheter Gauge: 10 French
• Length: 10 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Catheter Gauge: 10 French
• Length: 10 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Catheter Gauge: 10 French
• Length: 10 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Catheter Gauge: 10 French
• Length: 10 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Catheter Gauge: 10 French
• Length: 10 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Catheter Gauge: 10 French
• Length: 10 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Catheter Gauge: 10 French
• Length: 10 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Catheter Gauge: 10 French
• Length: 10 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Catheter Gauge: 10 French
• Length: 10 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Catheter Gauge: 10 French
• Length: 10 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Catheter Gauge: 10 French
• Length: 10 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Catheter Gauge: 10 French
• Length: 10 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Catheter Gauge: 10 French
• Length: 10 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Catheter Gauge: 10 French
• Length: 10 Centimeter
• Lumen/Inner Diameter: 8 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00733132615650 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041423
• Premarket Notification: K081184

FDA Product Code

• FGE: Catheter, Biliary, Diagnostic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-01-29
• Device Publish Date: 2016-03-07

On-Brand Devices [GORE VIABIL Biliary Endoprosthesis]

• 00733132638895: VSWVN0804
• 00733132638888: VSWVN1010
• 00733132638871: VSWVN1008
• 00733132638864: VSWVN1006
• 00733132638857: VSWVN1004
• 00733132638840: VSWVN0810
• 00733132638833: VSWVN0808
• 00733132638826: VSWVN0806
• 00733132638819: VSWVH1010
• 00733132638802: VSWVH1008
• 00733132638796: VSWVH1006
• 00733132638789: VSWVH0810
• 00733132638772: VSWVH0808
• 00733132638765: VSWVH0806
• 00733132615834: VN1010200
• 00733132615810: VN1010040
• 00733132615797: VN1008200
• 00733132615773: VN1008040
• 00733132615759: VN1006200
• 00733132615735: VN1006040
• 00733132615711: VN1004200
• 00733132615698: VN1004040
• 00733132615674: VN0810200
• 00733132615650: VN0810040
• 00733132615636: VN0808200
• 00733132615612: VN0808040
• 00733132615599: VN0806200
• 00733132615575: VN0806040
• 00733132615551: VN0804200
• 00733132615537: VN0804040
• 00733132615520: VH1010200
• 00733132615513: VH1010040
• 00733132615506: VH1008200
• 00733132615490: VH1008040
• 00733132615483: VH1006200
• 00733132615476: VH1006040
• 00733132615469: VH0810200
• 00733132615452: VH0810040
• 00733132615445: VH0808200
• 00733132615438: VH0808040
• 00733132615421: VH0806200
• 00733132615414: VH0806040