Home GUDID 00733132607006 GORE HELEX Septal Occluder
Primary DI 00733132607006
Brand GORE HELEX Septal Occluder
Company W. L. Gore & Associates, Inc.
Model HX2030
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 00733132607006 Primary GS1 0 H373HX203030 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 00733132607006 00733132607006 733132607006 0733132607006
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 30 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 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# 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 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 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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