Home GUDID H373PXL16140730 GORE EXCLUDER AAA Endoprosthesis
Primary DI H373PXL16140730
Brand GORE EXCLUDER AAA Endoprosthesis
Company W. L. Gore & Associates, Inc.
Model PXL161407
Catalog number PXL161407
Device description Iliac Extender
Published 2015-11-27
Public version status Update
Distribution status In Commercial Distribution
MRI safety MR Conditional
Rx true
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name MIH System, Endovascular Graft, Aortic Aneurysm Treatment
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown 3
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00733132610082 Primary GS1 0 H373PXL16140730 Secondary HIBCC 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00733132610082 00733132610082 733132610082 0733132610082
GMDN Terms# Term, Definition table Term Definition Abdominal aorta endovascular stent-graft A sterile non-bioabsorbable tubular device typically implanted at the junction of the abdominal aorta and the common iliac arteries to reduce pressure on an abdominal aortic aneurysm (AAA). It is percutaneously inserted via the femoral artery to the site of implantation, with a disposable delivery device, where it self-expands. It is typically made of nickel-titanium alloy (Nitinol) that forms an outer mesh structure with an inner polymer tube (endovascular graft). It is typically available in two designs: 1) a single continuous tube for insertion into one iliac artery; or 2) a two-part bifurcation design (e.g., shaped as a Y in a tube form) for insertion through both iliac arteries.
Device Sizes# Type, Value, Unit table Type Value Unit Length 7 Centimeter Lumen/Inner Diameter 14.5 Millimeter Lumen/Inner Diameter 16 Millimeter
Regulatory Flags# DUNS number 967358115 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch false Serial number true Manufacturing date on label true Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00733132606290 GORE PROPATEN Vascular Graft Pediatric Shunt HPT040015A HPT040015A 2017-02-13 00733132606313 GORE PROPATEN Vascular Graft Pediatric Shunt HPT050005A HPT050005A 2017-02-13 00733132606351 GORE PROPATEN Vascular Graft Pediatric Shunt HPT050015A HPT050015A 2017-02-13 00733132606375 GORE PROPATEN Vascular Graft Pediatric Shunt HPT060015A HPT060015A 2017-02-13 00733132606399 GORE PROPATEN Vascular Graft Pediatric Shunt HPT350005A HPT350005A 2017-02-13 00733132606436 GORE PROPATEN Vascular Graft Pediatric Shunt HPT350015A HPT350015A 2017-02-13 00733132607068 GORE PROPATEN Vascular Graft IRH060545A IRH060545A 2017-02-13 00733132607129 GORE PROPATEN Vascular Graft IRH463845A IRH463845A 2017-02-13 00733132607143 GORE PROPATEN Vascular Graft IRH473845A IRH473845A 2017-02-13 00733132653690 GORE SYNECOR Preperitoneal Biomaterial GKWR4040 GKWR4040 2022-11-08 00733132653706 GORE SYNECOR Preperitoneal Biomaterial GKWR3030 GKWR3030 2022-11-08 00733132653713 GORE SYNECOR Preperitoneal Biomaterial GKWR4050 GKWR4050 2022-11-08 00733132653720 GORE SYNECOR Preperitoneal Biomaterial GKWR3535 GKWR3535 2022-11-08 00733132653737 GORE SYNECOR Preperitoneal Biomaterial GKWR3040 GKWR3040 2022-11-08 00733132653744 GORE SYNECOR Preperitoneal Biomaterial GKWC09 GKWC09 2021-10-05 00733132605798 GORE PROPATEN Vascular Graft H060010A H060010A 2017-02-13 00733132605811 GORE PROPATEN Vascular Graft H060040A H060040A 2017-02-13 00733132605835 GORE PROPATEN Vascular Graft H060060A H060060A 2017-02-13 00733132605859 GORE PROPATEN Vascular Graft H060080A H060080A 2017-02-13 00733132605873 GORE PROPATEN Vascular Graft H080040A H080040A 2017-02-13
Other Devices Sharing Product Codes# 
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