GORE VIABAHN VBX Balloon Expandable Endo BXB061501A

GUDID 00733132658374

BX2 HEP REDUCED PROFILE BX2 6MMX15MM 6Fr 80CM Cath

W. L. Gore & Associates, Inc.

Peripheral artery endovascular stent-graft, drug-coated

• Primary Device ID: 00733132658374
• NIH Device Record Key: bef4fa36-814b-4c9c-bbee-f844493c569b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GORE VIABAHN VBX Balloon Expandable Endo
• Version Model Number: BXB061501A
• Catalog Number: BXB061501A
• 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: false
• 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

Device Dimensions

• Lumen/Inner Diameter: 6 Millimeter
• Catheter Gauge: 6 French
• Length: 1.5 Centimeter
• Lumen/Inner Diameter: 6 Millimeter
• Catheter Gauge: 6 French
• Length: 1.5 Centimeter
• Lumen/Inner Diameter: 6 Millimeter
• Catheter Gauge: 6 French
• Length: 1.5 Centimeter
• Lumen/Inner Diameter: 6 Millimeter
• Catheter Gauge: 6 French
• Length: 1.5 Centimeter
• Lumen/Inner Diameter: 6 Millimeter
• Catheter Gauge: 6 French
• Length: 1.5 Centimeter
• Lumen/Inner Diameter: 6 Millimeter
• Catheter Gauge: 6 French
• Length: 1.5 Centimeter
• Lumen/Inner Diameter: 6 Millimeter
• Catheter Gauge: 6 French
• Length: 1.5 Centimeter
• Lumen/Inner Diameter: 6 Millimeter
• Catheter Gauge: 6 French
• Length: 1.5 Centimeter
• Lumen/Inner Diameter: 6 Millimeter
• Catheter Gauge: 6 French
• Length: 1.5 Centimeter
• Lumen/Inner Diameter: 6 Millimeter
• Catheter Gauge: 6 French
• Length: 1.5 Centimeter
• Lumen/Inner Diameter: 6 Millimeter
• Catheter Gauge: 6 French
• Length: 1.5 Centimeter
• Lumen/Inner Diameter: 6 Millimeter
• Catheter Gauge: 6 French
• Length: 1.5 Centimeter
• Lumen/Inner Diameter: 6 Millimeter
• Catheter Gauge: 6 French
• Length: 1.5 Centimeter
• Lumen/Inner Diameter: 6 Millimeter
• Catheter Gauge: 6 French
• Length: 1.5 Centimeter
• Lumen/Inner Diameter: 6 Millimeter
• Catheter Gauge: 6 French
• Length: 1.5 Centimeter
• Lumen/Inner Diameter: 6 Millimeter
• Catheter Gauge: 6 French
• Length: 1.5 Centimeter
• Lumen/Inner Diameter: 6 Millimeter
• Catheter Gauge: 6 French
• Length: 1.5 Centimeter
• Lumen/Inner Diameter: 6 Millimeter
• Catheter Gauge: 6 French
• Length: 1.5 Centimeter
• Lumen/Inner Diameter: 6 Millimeter
• Catheter Gauge: 6 French
• Length: 1.5 Centimeter
• Lumen/Inner Diameter: 6 Millimeter
• Catheter Gauge: 6 French
• Length: 1.5 Centimeter
• Lumen/Inner Diameter: 6 Millimeter
• Catheter Gauge: 6 French
• Length: 1.5 Centimeter
• Lumen/Inner Diameter: 6 Millimeter
• Catheter Gauge: 6 French
• Length: 1.5 Centimeter
• Lumen/Inner Diameter: 6 Millimeter
• Catheter Gauge: 6 French
• Length: 1.5 Centimeter
• Lumen/Inner Diameter: 6 Millimeter
• Catheter Gauge: 6 French
• Length: 1.5 Centimeter
• Lumen/Inner Diameter: 6 Millimeter
• Catheter Gauge: 6 French
• Length: 1.5 Centimeter
• Lumen/Inner Diameter: 6 Millimeter
• Catheter Gauge: 6 French
• Length: 1.5 Centimeter
• Lumen/Inner Diameter: 6 Millimeter
• Catheter Gauge: 6 French
• Length: 1.5 Centimeter
• Lumen/Inner Diameter: 6 Millimeter
• Catheter Gauge: 6 French
• Length: 1.5 Centimeter
• Lumen/Inner Diameter: 6 Millimeter
• Catheter Gauge: 6 French
• Length: 1.5 Centimeter
• Lumen/Inner Diameter: 6 Millimeter
• Catheter Gauge: 6 French
• Length: 1.5 Centimeter
• Lumen/Inner Diameter: 6 Millimeter
• Catheter Gauge: 6 French
• Length: 1.5 Centimeter
• Lumen/Inner Diameter: 6 Millimeter
• Catheter Gauge: 6 French
• Length: 1.5 Centimeter
• Lumen/Inner Diameter: 6 Millimeter
• Catheter Gauge: 6 French
• Length: 1.5 Centimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00733132658374 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-12-19
• Device Publish Date: 2023-12-11

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