GORE VIABAHN VBX Balloon Expandable Endo BXA053901A

GUDID 00733132637102

W. L. Gore & Associates, Inc.

Multiple peripheral artery stent, bare-metal

• Primary Device ID: 00733132637102
• NIH Device Record Key: aa851dec-e248-4018-8efb-5e8b7145349e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GORE VIABAHN VBX Balloon Expandable Endo
• Version Model Number: BXA053901A
• Catalog Number: BXA053901A
• 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: true
• 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
• 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

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 39 Millimeter
• Outer Diameter: 5 Millimeter
• Catheter Gauge: 7 French
• Device Size Text, specify: 0
• Length: 39 Millimeter
• Outer Diameter: 5 Millimeter
• Catheter Gauge: 7 French
• Device Size Text, specify: 0
• Length: 39 Millimeter
• Outer Diameter: 5 Millimeter
• Catheter Gauge: 7 French
• Device Size Text, specify: 0
• Length: 39 Millimeter
• Outer Diameter: 5 Millimeter
• Catheter Gauge: 7 French
• Device Size Text, specify: 0
• Length: 39 Millimeter
• Outer Diameter: 5 Millimeter
• Catheter Gauge: 7 French
• Device Size Text, specify: 0
• Length: 39 Millimeter
• Outer Diameter: 5 Millimeter
• Catheter Gauge: 7 French
• Device Size Text, specify: 0
• Length: 39 Millimeter
• Outer Diameter: 5 Millimeter
• Catheter Gauge: 7 French
• Device Size Text, specify: 0
• Length: 39 Millimeter
• Outer Diameter: 5 Millimeter
• Catheter Gauge: 7 French
• Device Size Text, specify: 0
• Length: 39 Millimeter
• Outer Diameter: 5 Millimeter
• Catheter Gauge: 7 French
• Device Size Text, specify: 0
• Length: 39 Millimeter
• Outer Diameter: 5 Millimeter
• Catheter Gauge: 7 French
• Device Size Text, specify: 0
• Length: 39 Millimeter
• Outer Diameter: 5 Millimeter
• Catheter Gauge: 7 French
• Device Size Text, specify: 0
• Length: 39 Millimeter
• Outer Diameter: 5 Millimeter
• Catheter Gauge: 7 French
• Device Size Text, specify: 0
• Length: 39 Millimeter
• Outer Diameter: 5 Millimeter
• Catheter Gauge: 7 French
• Device Size Text, specify: 0
• Length: 39 Millimeter
• Outer Diameter: 5 Millimeter
• Catheter Gauge: 7 French
• Device Size Text, specify: 0
• Length: 39 Millimeter
• Outer Diameter: 5 Millimeter
• Catheter Gauge: 7 French
• Device Size Text, specify: 0
• Length: 39 Millimeter
• Outer Diameter: 5 Millimeter
• Catheter Gauge: 7 French
• Device Size Text, specify: 0
• Length: 39 Millimeter
• Outer Diameter: 5 Millimeter
• Catheter Gauge: 7 French
• Device Size Text, specify: 0
• Length: 39 Millimeter
• Outer Diameter: 5 Millimeter
• Catheter Gauge: 7 French
• Device Size Text, specify: 0
• Length: 39 Millimeter
• Outer Diameter: 5 Millimeter
• Catheter Gauge: 7 French
• Device Size Text, specify: 0
• Length: 39 Millimeter
• Outer Diameter: 5 Millimeter
• Catheter Gauge: 7 French
• Device Size Text, specify: 0
• Length: 39 Millimeter
• Outer Diameter: 5 Millimeter
• Catheter Gauge: 7 French
• Device Size Text, specify: 0
• Length: 39 Millimeter
• Outer Diameter: 5 Millimeter
• Catheter Gauge: 7 French
• Device Size Text, specify: 0
• Length: 39 Millimeter
• Outer Diameter: 5 Millimeter
• Catheter Gauge: 7 French
• Device Size Text, specify: 0
• Length: 39 Millimeter
• Outer Diameter: 5 Millimeter
• Catheter Gauge: 7 French
• Device Size Text, specify: 0
• Length: 39 Millimeter
• Outer Diameter: 5 Millimeter
• Catheter Gauge: 7 French
• Device Size Text, specify: 0
• Length: 39 Millimeter
• Outer Diameter: 5 Millimeter
• Catheter Gauge: 7 French
• Device Size Text, specify: 0
• Length: 39 Millimeter
• Outer Diameter: 5 Millimeter
• Catheter Gauge: 7 French
• Device Size Text, specify: 0
• Length: 39 Millimeter
• Outer Diameter: 5 Millimeter
• Catheter Gauge: 7 French
• Device Size Text, specify: 0
• Length: 39 Millimeter
• Outer Diameter: 5 Millimeter
• Catheter Gauge: 7 French
• Device Size Text, specify: 0
• Length: 39 Millimeter
• Outer Diameter: 5 Millimeter
• Catheter Gauge: 7 French
• Device Size Text, specify: 0
• Length: 39 Millimeter
• Outer Diameter: 5 Millimeter
• Catheter Gauge: 7 French
• Device Size Text, specify: 0
• Length: 39 Millimeter
• Outer Diameter: 5 Millimeter
• Catheter Gauge: 7 French
• Device Size Text, specify: 0
• Length: 39 Millimeter
• Outer Diameter: 5 Millimeter
• Catheter Gauge: 7 French
• Device Size Text, specify: 0
• Length: 39 Millimeter
• Outer Diameter: 5 Millimeter
• Catheter Gauge: 7 French
• Device Size Text, specify: 0
• Length: 39 Millimeter
• Outer Diameter: 5 Millimeter
• Catheter Gauge: 7 French
• Device Size Text, specify: 0
• Length: 39 Millimeter
• Outer Diameter: 5 Millimeter
• Catheter Gauge: 7 French
• Device Size Text, specify: 0
• Length: 39 Millimeter
• Outer Diameter: 5 Millimeter
• Catheter Gauge: 7 French
• Device Size Text, specify: 0
• Length: 39 Millimeter
• Outer Diameter: 5 Millimeter
• Catheter Gauge: 7 French
• Device Size Text, specify: 0
• Length: 39 Millimeter
• Outer Diameter: 5 Millimeter
• Catheter Gauge: 7 French
• Device Size Text, specify: 0
• Length: 39 Millimeter
• Outer Diameter: 5 Millimeter
• Catheter Gauge: 7 French
• Device Size Text, specify: 0
• Length: 39 Millimeter
• Outer Diameter: 5 Millimeter
• Catheter Gauge: 7 French
• Device Size Text, specify: 0
• Length: 39 Millimeter
• Outer Diameter: 5 Millimeter
• Catheter Gauge: 7 French
• Device Size Text, specify: 0
• Length: 39 Millimeter
• Outer Diameter: 5 Millimeter
• Catheter Gauge: 7 French
• Device Size Text, specify: 0
• Length: 39 Millimeter
• Outer Diameter: 5 Millimeter
• Catheter Gauge: 7 French
• Device Size Text, specify: 0
• Length: 39 Millimeter
• Outer Diameter: 5 Millimeter
• Catheter Gauge: 7 French
• Device Size Text, specify: 0
• Length: 39 Millimeter
• Outer Diameter: 5 Millimeter
• Catheter Gauge: 7 French
• Device Size Text, specify: 0
• Length: 39 Millimeter
• Outer Diameter: 5 Millimeter
• Catheter Gauge: 7 French
• Device Size Text, specify: 0
• Length: 39 Millimeter
• Outer Diameter: 5 Millimeter
• Catheter Gauge: 7 French
• Device Size Text, specify: 0
• Length: 39 Millimeter
• Outer Diameter: 5 Millimeter
• Catheter Gauge: 7 French
• Device Size Text, specify: 0
• Length: 39 Millimeter
• Outer Diameter: 5 Millimeter
• Catheter Gauge: 7 French
• Device Size Text, specify: 0
• Length: 39 Millimeter
• Outer Diameter: 5 Millimeter
• Catheter Gauge: 7 French
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00733132637102 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P160021

FDA Product Code

• PRL: Iliac Covered Stent, Arterial

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: 2017-01-31

On-Brand Devices [GORE VIABAHN VBX Balloon Expandable Endo]

• 00733132637836: BXAL085901A
• 00733132637829: BXAL083902A
• 00733132637812: BXAL083901A
• 00733132637805: BXAL082902A
• 00733132637799: BXA087902A
• 00733132637768: BXA117902A
• 00733132637751: BXA117901A
• 00733132637744: BXA115902A
• 00733132637737: BXA115901A
• 00733132637720: BXA113902A
• 00733132637713: BXA113901A
• 00733132637706: BXA112902A
• 00733132637690: BXA112901A
• 00733132637683: BXAL087901A
• 00733132637676: BXAL087902A
• 00733132637669: BXAL085902A
• 00733132637652: BXAL082901A
• 00733132637645: BXA107902A
• 00733132637638: BXA107901A
• 00733132637621: BXA102902A
• 00733132637614: BXA102901A
• 00733132637607: BXA097902A
• 00733132637591: BXA097901A
• 00733132637584: BXA092902A
• 00733132637577: BXA092901A
• 00733132637560: BXA087901A
• 00733132637553: BXA082902A
• 00733132637546: BXA082901A
• 00733132637539: BXA077902A
• 00733132637522: BXA077901A
• 00733132637515: BXA072902A
• 00733132637508: BXA072901A
• 00733132637492: BXA067902A
• 00733132637485: BXA067901A
• 00733132637478: BXA062902A
• 00733132637461: BXA062901A
• 00733132637454: BXA057902A
• 00733132637447: BXA057901A
• 00733132637430: BXA052902A
• 00733132637423: BXA052901A
• 00733132637416: BXA105902A
• 00733132637409: BXA105901A
• 00733132637393: BXA103902A
• 00733132637386: BXA103901A
• 00733132637379: BXA095902A
• 00733132637362: BXA095901A
• 00733132637355: BXA093902A
• 00733132637348: BXA093901A
• 00733132637331: BXA085902A
• 00733132637324: BXA085901A