GORE EXCLUDER AAA Endoprosthesis PXL161007

GUDID H373PXL1610073

Iliac Extender

W. L. Gore & Associates, Inc.

Abdominal aorta endovascular stent-graft

• Primary Device ID: H373PXL1610073
• NIH Device Record Key: 359204ec-af1d-457f-b208-b9d085735025
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GORE EXCLUDER AAA Endoprosthesis
• Version Model Number: PXL161007
• Catalog Number: PXL161007
• 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

Device Dimensions

• Length: 7 Centimeter
• Length: 7 Centimeter
• Length: 7 Centimeter
• Length: 7 Centimeter
• Length: 7 Centimeter
• Length: 7 Centimeter
• Lumen/Inner Diameter: 16 Millimeter
• Lumen/Inner Diameter: 10 Millimeter
• Length: 7 Centimeter
• Lumen/Inner Diameter: 16 Millimeter
• Lumen/Inner Diameter: 10 Millimeter
• Length: 7 Centimeter
• Lumen/Inner Diameter: 16 Millimeter
• Lumen/Inner Diameter: 10 Millimeter
• Length: 7 Centimeter
• Lumen/Inner Diameter: 16 Millimeter
• Lumen/Inner Diameter: 10 Millimeter
• Length: 7 Centimeter
• Lumen/Inner Diameter: 16 Millimeter
• Lumen/Inner Diameter: 10 Millimeter
• Length: 7 Centimeter
• Lumen/Inner Diameter: 16 Millimeter
• Lumen/Inner Diameter: 10 Millimeter
• Length: 7 Centimeter
• Lumen/Inner Diameter: 16 Millimeter
• Lumen/Inner Diameter: 10 Millimeter
• Length: 7 Centimeter
• Lumen/Inner Diameter: 16 Millimeter
• Lumen/Inner Diameter: 10 Millimeter
• Length: 7 Centimeter
• Lumen/Inner Diameter: 16 Millimeter
• Lumen/Inner Diameter: 10 Millimeter
• Length: 7 Centimeter
• Lumen/Inner Diameter: 16 Millimeter
• Lumen/Inner Diameter: 10 Millimeter
• Length: 7 Centimeter
• Lumen/Inner Diameter: 16 Millimeter
• Lumen/Inner Diameter: 10 Millimeter
• Length: 7 Centimeter
• Lumen/Inner Diameter: 16 Millimeter
• Lumen/Inner Diameter: 10 Millimeter
• Length: 7 Centimeter
• Lumen/Inner Diameter: 16 Millimeter
• Lumen/Inner Diameter: 10 Millimeter
• Length: 7 Centimeter
• Lumen/Inner Diameter: 16 Millimeter
• Lumen/Inner Diameter: 10 Millimeter
• Length: 7 Centimeter
• Lumen/Inner Diameter: 16 Millimeter
• Lumen/Inner Diameter: 10 Millimeter
• Length: 7 Centimeter
• Lumen/Inner Diameter: 16 Millimeter
• Lumen/Inner Diameter: 10 Millimeter
• Length: 7 Centimeter
• Lumen/Inner Diameter: 16 Millimeter
• Lumen/Inner Diameter: 10 Millimeter
• Length: 7 Centimeter
• Lumen/Inner Diameter: 16 Millimeter
• Lumen/Inner Diameter: 10 Millimeter
• Length: 7 Centimeter
• Lumen/Inner Diameter: 16 Millimeter
• Lumen/Inner Diameter: 10 Millimeter
• Length: 7 Centimeter
• Lumen/Inner Diameter: 16 Millimeter
• Lumen/Inner Diameter: 10 Millimeter
• Length: 7 Centimeter
• Lumen/Inner Diameter: 16 Millimeter
• Lumen/Inner Diameter: 10 Millimeter
• Length: 7 Centimeter
• Lumen/Inner Diameter: 16 Millimeter
• Lumen/Inner Diameter: 10 Millimeter
• Length: 7 Centimeter
• Lumen/Inner Diameter: 16 Millimeter
• Lumen/Inner Diameter: 10 Millimeter
• Length: 7 Centimeter
• Lumen/Inner Diameter: 16 Millimeter
• Lumen/Inner Diameter: 10 Millimeter
• Length: 7 Centimeter
• Lumen/Inner Diameter: 16 Millimeter
• Lumen/Inner Diameter: 10 Millimeter
• Length: 7 Centimeter
• Lumen/Inner Diameter: 16 Millimeter
• Lumen/Inner Diameter: 10 Millimeter
• Length: 7 Centimeter
• Lumen/Inner Diameter: 16 Millimeter
• Lumen/Inner Diameter: 10 Millimeter
• Length: 7 Centimeter
• Lumen/Inner Diameter: 16 Millimeter
• Lumen/Inner Diameter: 10 Millimeter
• Length: 7 Centimeter
• Lumen/Inner Diameter: 16 Millimeter
• Lumen/Inner Diameter: 10 Millimeter
• Length: 7 Centimeter
• Lumen/Inner Diameter: 16 Millimeter
• Lumen/Inner Diameter: 10 Millimeter
• Length: 7 Centimeter
• Lumen/Inner Diameter: 16 Millimeter
• Lumen/Inner Diameter: 10 Millimeter
• Length: 7 Centimeter
• Lumen/Inner Diameter: 16 Millimeter
• Lumen/Inner Diameter: 10 Millimeter
• Length: 7 Centimeter
• Lumen/Inner Diameter: 16 Millimeter
• Lumen/Inner Diameter: 10 Millimeter
• Length: 7 Centimeter
• Lumen/Inner Diameter: 16 Millimeter
• Lumen/Inner Diameter: 10 Millimeter
• Length: 7 Centimeter
• Lumen/Inner Diameter: 16 Millimeter
• Lumen/Inner Diameter: 10 Millimeter
• Length: 7 Centimeter
• Lumen/Inner Diameter: 16 Millimeter
• Lumen/Inner Diameter: 10 Millimeter
• Length: 7 Centimeter
• Lumen/Inner Diameter: 16 Millimeter
• Lumen/Inner Diameter: 10 Millimeter
• Length: 7 Centimeter
• Lumen/Inner Diameter: 16 Millimeter
• Lumen/Inner Diameter: 10 Millimeter
• Length: 7 Centimeter
• Lumen/Inner Diameter: 16 Millimeter
• Lumen/Inner Diameter: 10 Millimeter
• Length: 7 Centimeter
• Lumen/Inner Diameter: 16 Millimeter
• Lumen/Inner Diameter: 10 Millimeter
• Length: 7 Centimeter
• Lumen/Inner Diameter: 16 Millimeter
• Lumen/Inner Diameter: 10 Millimeter
• Length: 7 Centimeter
• Lumen/Inner Diameter: 16 Millimeter
• Lumen/Inner Diameter: 10 Millimeter
• Length: 7 Centimeter
• Lumen/Inner Diameter: 16 Millimeter
• Lumen/Inner Diameter: 10 Millimeter
• Length: 7 Centimeter
• Lumen/Inner Diameter: 16 Millimeter
• Lumen/Inner Diameter: 10 Millimeter
• Length: 7 Centimeter
• Lumen/Inner Diameter: 16 Millimeter
• Lumen/Inner Diameter: 10 Millimeter
• Length: 7 Centimeter
• Lumen/Inner Diameter: 16 Millimeter
• Lumen/Inner Diameter: 10 Millimeter
• Length: 7 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00733132610068 [Primary]
HIBCC	H373PXL1610073 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P020004

FDA Product Code

• MIH: System, Endovascular Graft, Aortic Aneurysm Treatment

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: 2019-01-24
• Device Publish Date: 2015-11-27

On-Brand Devices [GORE EXCLUDER AAA Endoprosthesis]

• H373RLT2812163: Trunk-Ipsilateral Leg
• 00733132618811: EXCLUDER 16MMX10MMX7CM Iliac Extender
• 00733132618804: Aortic Extender
• 00733132618798: EXCLUDER 16MMX12MMX7CM Iliac Extender
• 00733132618781: Aortic Extender
• 00733132618774: Aortic Extender
• 00733132618767: EXCLUDER 16MMX14.5MMX7CM Iliac Extender
• 00733132618750: Aortic Extender
• 00733132618743: Contralateral Leg
• 00733132618736: Contralateral Leg
• 00733132618729: Contralateral Leg
• 00733132618712: EXCLUDER 12MMX12CM Contralateral Leg
• 00733132618705: Contralateral Leg
• 00733132618699: Contralateral Leg
• H373PLC20120038: Contralateral Leg
• 00733132618675: EXCLUDER 14.5MMX12CM Contralateral Leg
• 00733132618668: Contralateral Leg
• 00733132618651: EXCLUDER 14.5MMX14CM Contralateral Leg
• 00733132618644: EXCLUDER 12MMX14CM Contralateral Leg
• 00733132618637: EXCLUDER 14.5MMX10CM Contralateral Leg
• 00733132618613: EXCLUDER 12MMX10CM Contralateral Leg
• 00733132618606: Contralateral Leg
• H373PLC20100036: Contralateral Leg
• 00733132618583: Contralateral Leg
• H373PLC23100039: Contralateral Leg
• 00733132618569: Contralateral Leg
• 00733132618552: Contralateral Leg
• 00733132618545: Contralateral Leg
• 00733132618538: Contralateral Leg
• 00733132618439: Aortic Extender
• 00733132618309: Contralateral Leg
• 00733132618293: Contralateral Leg
• 00733132618248: Contralateral Leg
• 00733132618231: Contralateral Leg
• 00733132618224: Contralateral Leg
• 00733132618217: Contralateral Leg
• H373RMT2312183: RMT231218
• H373PXT31141736: PXT311417
• H373PXT31141534: PXT311415
• H373PXT31141332: PXT311413
• 00733132610327: Trunk-Ipsilateral Leg
• 00733132610310: Trunk-Ipsilateral Leg
• H373PXT28141439: PXT281414
• H373PXT28141237: PXT281412
• 00733132610280: Trunk-Ipsilateral Leg
• H373PXT28121639: PXT281216
• H373PXT28121437: PXT281214
• H373PXT28121235: PXT281212
• 00733132610242: Trunk-Ipsilateral Leg
• H373PXT26141639: PXT261416