Home GUDID 00733132607013 GORE HELEX Septal Occluder
Primary DI 00733132607013
Brand GORE HELEX Septal Occluder
Company W. L. Gore & Associates, Inc.
Model HX2035
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 00733132607013 Primary GS1 0 H373HX203535 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 00733132607013 00733132607013 733132607013 0733132607013
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 35 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 00733132666980 GORE® TAG® Thoracic Branch Endoprosthesis TAC123110A TAC123110A 2026-05-26 00733132666997 GORE® TAG® Thoracic Branch Endoprosthesis TAC123410A TAC123410A 2026-05-26 00733132667000 GORE® TAG® Thoracic Branch Endoprosthesis TAC123710A TAC123710A 2026-05-26 00733132667017 GORE® TAG® Thoracic Branch Endoprosthesis TAC124010A TAC124010A 2026-05-26 00733132667024 GORE® TAG® Thoracic Branch Endoprosthesis TAC124510A TAC124510A 2026-05-26 00733132607211 GORE INTERING Vascular Graft IRST06005005L IRST06005005L 2017-02-13 00733132610457 GORE-TEX Vascular Graft R20030030 R20030030 2017-01-10 00733132612505 GORE-TEX STRETCH Vascular Graft Pediatric Shunt ST03005A ST03005A 2017-01-10 00733132612512 GORE-TEX Vascular Graft Pediatric Shunt ST03010A ST03010A 2017-01-10 00733132612536 GORE-TEX Vascular Graft Pediatric Shunt ST04010A ST04010A 2017-01-10 00733132612543 GORE-TEX Vascular Graft Pediatric Shunt ST04015A ST04015A 2017-01-10 00733132612567 GORE-TEX Vascular Graft ST05010A ST05010A 2017-01-10 00733132612574 GORE-TEX Vascular Graft ST05015A ST05015A 2017-01-10 00733132612604 GORE-TEX Vascular Graft ST06015A ST06015A 2017-01-10 00733132612802 GORE-TEX Vascular Graft ST35005A ST35005A 2017-01-10 00733132612819 GORE-TEX Vascular Graft ST35010A ST35010A 2017-01-10 00733132612826 GORE-TEX Vascular Graft ST35015A ST35015A 2017-01-10 00733132615131 GORE VIABAHN Endoprosthesis with Heparin VBH101002 VBH101002 2015-11-17 00733132615179 GORE VIABAHN Endoprosthesis with Heparin VBH111002 VBH111002 2015-11-17 00733132615858 GORE-TEX Vascular Graft Pediatric Shunt VT03010LA VT03010LA 2017-02-13
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 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 00733132606979 GORE HELEX Septal Occluder W. L. Gore & Associates, Inc. MLV 2017-02-13 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 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 00811806011288 Amplatzer™ ST. JUDE MEDICAL, INC. MLV 2016-11-08
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