Home GUDID 00733132606979 GORE HELEX Septal Occluder
Primary DI 00733132606979
Brand GORE HELEX Septal Occluder
Company W. L. Gore & Associates, Inc.
Model HX2015
Published 2017-02-13
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety MR Conditional
Rx true
Sterile true
Single use true Product Codes# Code, Name table Code Name MLV Transcatheter Septal Occluder
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class MLV Transcatheter Septal Occluder Unknown 3
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00733132606979 Primary GS1 0 H373HX201533 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 00733132606979 00733132606979 733132606979 0733132606979
GMDN Terms# Term, Definition table Term Definition Cardiac defect occluder An implantable disk-like device intended to be used for the minimally-invasive closure of cardiac defects and deployed using a dedicated delivery catheter/sheath. It is made of wire mesh [e.g., nickel-titanium alloy (Nitinol)], and possibly additional materials (e.g., polyester), and is typically self-expandable. The device is used to treat cardiac disorders that may include (but not limited to) atrial septal defect (ASD), ventricular septal defect (VSD), patent foramen ovale (PFO), or patent ductus arteriosus (PDA). Disposable devices dedicated to implantation may be included with the implant.
Device Sizes# Type, Value, Unit table Type Value Unit Length 75 Centimeter Outer Diameter 15 Millimeter
Regulatory Flags# DUNS number 967358115 Device count 1 Serial number true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00733132658855 GORE® DrySeal Flex Introducer Sheath GDSF1033 GDSF1033 2024-12-02 00733132658862 GORE® DrySeal Flex Introducer Sheath GDSF1045 GDSF1045 2024-12-02 00733132658879 GORE® DrySeal Flex Introducer Sheath GDSF1065 GDSF1065 2024-12-02 00733132658886 GORE® DrySeal Flex Introducer Sheath GDSF1133 GDSF1133 2024-12-02 00733132658893 GORE® DrySeal Flex Introducer Sheath GDSF1233 GDSF1233 2024-12-02 00733132658909 GORE® DrySeal Flex Introducer Sheath GDSF1245 GDSF1245 2024-12-02 00733132658916 GORE® DrySeal Flex Introducer Sheath GDSF1265 GDSF1265 2024-12-02 00733132658923 GORE® DrySeal Flex Introducer Sheath GDSF1433 GDSF1433 2024-12-02 00733132658930 GORE® DrySeal Flex Introducer Sheath GDSF1465 GDSF1465 2024-12-02 00733132658947 GORE® DrySeal Flex Introducer Sheath GDSF1533 GDSF1533 2024-12-02 00733132658954 GORE® DrySeal Flex Introducer Sheath GDSF1633 GDSF1633 2024-12-02 00733132658961 GORE® DrySeal Flex Introducer Sheath GDSF1665 GDSF1665 2024-12-02 00733132658978 GORE® DrySeal Flex Introducer Sheath GDSF1833 GDSF1833 2024-12-02 00733132658985 GORE® DrySeal Flex Introducer Sheath GDSF1865 GDSF1865 2024-12-02 00733132658992 GORE® DrySeal Flex Introducer Sheath GDSF2033 GDSF2033 2024-12-02 00733132659005 GORE® DrySeal Flex Introducer Sheath GDSF2065 GDSF2065 2024-12-02 00733132659012 GORE® DrySeal Flex Introducer Sheath GDSF2233 GDSF2233 2024-12-02 00733132659029 GORE® DrySeal Flex Introducer Sheath GDSF2265 GDSF2265 2024-12-02 00733132659036 GORE® DrySeal Flex Introducer Sheath GDSF2433 GDSF2433 2024-12-02 00733132659043 GORE® DrySeal Flex Introducer Sheath GDSF2465 GDSF2465 2024-12-02
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00811806011295 Amplatzer™ ST. JUDE MEDICAL, INC. MLV 2026-07-31 05415067033307 Amplatzer™ Talisman™ ST. JUDE MEDICAL, INC. MLV 2021-09-29 05415067033314 Amplatzer™ Talisman™ ST. JUDE MEDICAL, INC. MLV 2021-09-29 05415067033321 Amplatzer™ Talisman™ ST. JUDE MEDICAL, INC. MLV 2021-09-29 05415067033345 Amplatzer™ Talisman™ ST. JUDE MEDICAL, INC. MLV 2021-09-29 00733132636525 GORE CARDIOFORM ASD Occluder W. L. Gore & Associates, Inc. MLV 2019-08-07 00733132636488 GORE CARDIOFORM ASD Occluder W. L. Gore & Associates, Inc. MLV 2019-07-03 00733132636495 GORE CARDIOFORM ASD Occluder W. L. Gore & Associates, Inc. MLV 2019-07-03 00733132636501 GORE CARDIOFORM ASD Occluder W. L. Gore & Associates, Inc. MLV 2019-07-03 00733132636518 GORE CARDIOFORM ASD Occluder W. L. Gore & Associates, Inc. MLV 2019-07-03 05415067028105 Amplatzer™ AGA MEDICAL CORPORATION MLV 2017-02-22 05415067028112 Amplatzer™ AGA MEDICAL CORPORATION MLV 2017-02-22 05415067028129 Amplatzer™ AGA MEDICAL CORPORATION MLV 2017-02-22 05415067028136 Amplatzer™ AGA MEDICAL CORPORATION MLV 2017-02-22 05415067028143 Amplatzer™ AGA MEDICAL CORPORATION MLV 2017-02-22 00733132606986 GORE HELEX Septal Occluder W. L. Gore & Associates, Inc. MLV 2017-02-13 00733132606993 GORE HELEX Septal Occluder W. L. Gore & Associates, Inc. MLV 2017-02-13 00733132607006 GORE HELEX Septal Occluder W. L. Gore & Associates, Inc. MLV 2017-02-13 00733132607013 GORE HELEX Septal Occluder W. L. Gore & Associates, Inc. MLV 2017-02-13 H373HX201533 GORE HELEX Septal Occluder W. L. Gore & Associates, Inc. MLV 2017-02-13 H373HX20203 GORE HELEX Septal Occluder W. L. Gore & Associates, Inc. MLV 2017-02-13 H373HX202534 GORE HELEX Septal Occluder W. L. Gore & Associates, Inc. MLV 2017-02-13 H373HX203030 GORE HELEX Septal Occluder W. L. Gore & Associates, Inc. MLV 2017-02-13 H373HX203535 GORE HELEX Septal Occluder W. L. Gore & Associates, Inc. MLV 2017-02-13 00733132617609 Gore Septal Occluder W. L. Gore & Associates, Inc. MLV 2017-02-13 00733132631001 GORE CARDIOFORM Septal Occluder W. L. Gore & Associates, Inc. MLV 2017-02-13 00733132631018 GORE CARDIOFORM Septal Occluder W. L. Gore & Associates, Inc. MLV 2017-02-13 00733132631025 GORE CARDIOFORM Septal Occluder W. L. Gore & Associates, Inc. MLV 2017-02-13 00733132631032 GORE CARDIOFORM Septal Occluder W. L. Gore & Associates, Inc. MLV 2017-02-13 00811806011271 Amplatzer™ ST. JUDE MEDICAL, INC. MLV 2016-11-08
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