TIGRIS Vascular Stent PHA060801A

GUDID 00733132636266

W. L. Gore & Associates, Inc.

Multiple peripheral artery stent, bare-metal

• Primary Device ID: 00733132636266
• NIH Device Record Key: bc2e1f89-12dd-4367-a3dc-a25a805ba68f
• Commercial Distribution Discontinuation: 2020-01-01
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: TIGRIS Vascular Stent
• Version Model Number: PHA060801A
• Catalog Number: PHA060801A
• 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

Device Dimensions

• Length: 80 Millimeter
• Length: 80 Millimeter
• Length: 80 Millimeter
• Length: 80 Millimeter
• Length: 80 Millimeter
• Length: 80 Millimeter
• Catheter Gauge: 6 French
• Lumen/Inner Diameter: 6 Millimeter
• Length: 80 Millimeter
• Catheter Gauge: 6 French
• Lumen/Inner Diameter: 6 Millimeter
• Length: 80 Millimeter
• Catheter Gauge: 6 French
• Lumen/Inner Diameter: 6 Millimeter
• Length: 80 Millimeter
• Catheter Gauge: 6 French
• Lumen/Inner Diameter: 6 Millimeter
• Length: 80 Millimeter
• Catheter Gauge: 6 French
• Lumen/Inner Diameter: 6 Millimeter
• Length: 80 Millimeter
• Catheter Gauge: 6 French
• Lumen/Inner Diameter: 6 Millimeter
• Length: 80 Millimeter
• Catheter Gauge: 6 French
• Lumen/Inner Diameter: 6 Millimeter
• Length: 80 Millimeter
• Catheter Gauge: 6 French
• Lumen/Inner Diameter: 6 Millimeter
• Length: 80 Millimeter
• Catheter Gauge: 6 French
• Lumen/Inner Diameter: 6 Millimeter
• Length: 80 Millimeter
• Catheter Gauge: 6 French
• Lumen/Inner Diameter: 6 Millimeter
• Length: 80 Millimeter
• Catheter Gauge: 6 French
• Lumen/Inner Diameter: 6 Millimeter
• Length: 80 Millimeter
• Catheter Gauge: 6 French
• Lumen/Inner Diameter: 6 Millimeter
• Length: 80 Millimeter
• Catheter Gauge: 6 French
• Lumen/Inner Diameter: 6 Millimeter
• Length: 80 Millimeter
• Catheter Gauge: 6 French
• Lumen/Inner Diameter: 6 Millimeter
• Length: 80 Millimeter
• Catheter Gauge: 6 French
• Lumen/Inner Diameter: 6 Millimeter
• Length: 80 Millimeter
• Catheter Gauge: 6 French
• Lumen/Inner Diameter: 6 Millimeter
• Length: 80 Millimeter
• Catheter Gauge: 6 French
• Lumen/Inner Diameter: 6 Millimeter
• Length: 80 Millimeter
• Catheter Gauge: 6 French
• Lumen/Inner Diameter: 6 Millimeter
• Length: 80 Millimeter
• Catheter Gauge: 6 French
• Lumen/Inner Diameter: 6 Millimeter
• Length: 80 Millimeter
• Catheter Gauge: 6 French
• Lumen/Inner Diameter: 6 Millimeter
• Length: 80 Millimeter
• Catheter Gauge: 6 French
• Lumen/Inner Diameter: 6 Millimeter
• Length: 80 Millimeter
• Catheter Gauge: 6 French
• Lumen/Inner Diameter: 6 Millimeter
• Length: 80 Millimeter
• Catheter Gauge: 6 French
• Lumen/Inner Diameter: 6 Millimeter
• Length: 80 Millimeter
• Catheter Gauge: 6 French
• Lumen/Inner Diameter: 6 Millimeter
• Length: 80 Millimeter
• Catheter Gauge: 6 French
• Lumen/Inner Diameter: 6 Millimeter
• Length: 80 Millimeter
• Catheter Gauge: 6 French
• Lumen/Inner Diameter: 6 Millimeter
• Length: 80 Millimeter
• Catheter Gauge: 6 French
• Lumen/Inner Diameter: 6 Millimeter
• Length: 80 Millimeter
• Catheter Gauge: 6 French
• Lumen/Inner Diameter: 6 Millimeter
• Length: 80 Millimeter
• Catheter Gauge: 6 French
• Lumen/Inner Diameter: 6 Millimeter
• Length: 80 Millimeter
• Catheter Gauge: 6 French
• Lumen/Inner Diameter: 6 Millimeter
• Length: 80 Millimeter
• Catheter Gauge: 6 French
• Lumen/Inner Diameter: 6 Millimeter
• Length: 80 Millimeter
• Catheter Gauge: 6 French
• Lumen/Inner Diameter: 6 Millimeter
• Length: 80 Millimeter
• Catheter Gauge: 6 French
• Lumen/Inner Diameter: 6 Millimeter
• Length: 80 Millimeter
• Catheter Gauge: 6 French
• Lumen/Inner Diameter: 6 Millimeter
• Length: 80 Millimeter
• Catheter Gauge: 6 French
• Lumen/Inner Diameter: 6 Millimeter
• Length: 80 Millimeter
• Catheter Gauge: 6 French
• Lumen/Inner Diameter: 6 Millimeter
• Length: 80 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00733132636266 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P160004

FDA Product Code

• NIP: Stent, Superficial Femoral Artery

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 7
• Public Version Date: 2020-01-01
• Device Publish Date: 2016-08-03

On-Brand Devices [TIGRIS Vascular Stent]

• 00733132636396: PHA071002A
• 00733132636389: PHA071001A
• 00733132636372: PHA070802A
• 00733132636365: PHA070801A
• 00733132636358: PHA070602A
• 00733132636341: PHA070601A
• 00733132636334: PHA070402A
• 00733132636327: PHA070401A
• 00733132636310: PHA070302A
• 00733132636303: PHA070301A
• 00733132636297: PHA061002A
• 00733132636280: PHA061001A
• 00733132636273: PHA060802A
• 00733132636266: PHA060801A
• 00733132636259: PHA060602A
• 00733132636242: PHA060601A
• 00733132636235: PHA060402A
• 00733132636228: PHA060401A
• 00733132636211: PHA060302A
• 00733132636204: PHA060301A
• 00733132636198: PHA051002A
• 00733132636181: PHA051001A
• 00733132636174: PHA050802A
• 00733132636167: PHA050801A
• 00733132636150: PHA050602A
• 00733132636143: PHA050601A
• 00733132636136: PHA050402A
• 00733132636129: PHA050401A
• 00733132636112: PHA050302A
• 00733132636105: PHA050301A