GORE VIABIL Biliary Endoprosthesis VSWVN1004

GUDID 00733132638857

W. L. Gore & Associates, Inc.

Polymer-metal biliary stent

• Primary Device ID: 00733132638857
• NIH Device Record Key: 134c8b8e-a831-4104-bac5-37d024cfa4fc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GORE VIABIL Biliary Endoprosthesis
• Version Model Number: VSWVN1004
• Catalog Number: VSWVN1004
• 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: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com

Device Dimensions

• Length: 4 Centimeter
• Length: 4 Centimeter
• Length: 4 Centimeter
• Length: 4 Centimeter
• Length: 4 Centimeter
• Length: 4 Centimeter
• Length: 4 Centimeter
• Length: 4 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8.5 French
• Outer Diameter: 10 Millimeter
• Length: 4 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8.5 French
• Outer Diameter: 10 Millimeter
• Length: 4 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8.5 French
• Outer Diameter: 10 Millimeter
• Length: 4 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8.5 French
• Outer Diameter: 10 Millimeter
• Length: 4 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8.5 French
• Outer Diameter: 10 Millimeter
• Length: 4 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8.5 French
• Outer Diameter: 10 Millimeter
• Length: 4 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8.5 French
• Outer Diameter: 10 Millimeter
• Length: 4 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8.5 French
• Outer Diameter: 10 Millimeter
• Length: 4 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8.5 French
• Outer Diameter: 10 Millimeter
• Length: 4 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8.5 French
• Outer Diameter: 10 Millimeter
• Length: 4 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8.5 French
• Outer Diameter: 10 Millimeter
• Length: 4 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8.5 French
• Outer Diameter: 10 Millimeter
• Length: 4 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8.5 French
• Outer Diameter: 10 Millimeter
• Length: 4 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8.5 French
• Outer Diameter: 10 Millimeter
• Length: 4 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8.5 French
• Outer Diameter: 10 Millimeter
• Length: 4 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8.5 French
• Outer Diameter: 10 Millimeter
• Length: 4 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8.5 French
• Outer Diameter: 10 Millimeter
• Length: 4 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8.5 French
• Outer Diameter: 10 Millimeter
• Length: 4 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8.5 French
• Outer Diameter: 10 Millimeter
• Length: 4 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8.5 French
• Outer Diameter: 10 Millimeter
• Length: 4 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8.5 French
• Outer Diameter: 10 Millimeter
• Length: 4 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8.5 French
• Outer Diameter: 10 Millimeter
• Length: 4 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8.5 French
• Outer Diameter: 10 Millimeter
• Length: 4 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8.5 French
• Outer Diameter: 10 Millimeter
• Length: 4 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8.5 French
• Outer Diameter: 10 Millimeter
• Length: 4 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8.5 French
• Outer Diameter: 10 Millimeter
• Length: 4 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8.5 French
• Outer Diameter: 10 Millimeter
• Length: 4 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8.5 French
• Outer Diameter: 10 Millimeter
• Length: 4 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8.5 French
• Outer Diameter: 10 Millimeter
• Length: 4 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8.5 French
• Outer Diameter: 10 Millimeter
• Length: 4 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8.5 French
• Outer Diameter: 10 Millimeter
• Length: 4 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8.5 French
• Outer Diameter: 10 Millimeter
• Length: 4 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00733132638857 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170740

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-05-10

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