Home GUDID 00733132631001
GORE CARDIOFORM Septal Occluder
Primary DI 00733132631001
Brand GORE CARDIOFORM Septal Occluder
Company W. L. Gore & Associates, Inc.
Model GSX0015A
Catalog number GSX0015A
Device description CARDIOFORM SEPTAL OCCLUDER15MM
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 00733132631001 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00733132631001 00733132631001 733132631001 0733132631001
GMDN Terms# Term, Definition table Term Definition Cardiac occluder A sterile, disk-like, device used for the non-surgical closure of cardiac defects. The device is typically self-expandable and made of wire mesh [e.g., nickel-titanium alloy (Nitinol)], and possibly additional materials (e.g., polyester). It is implanted using a dedicated catheter/sheath and delivery cable. The device is used to treat cardiac disorders that may include, but not limited to; an atrial septal defect (ASD), a ventricular septal defect (VSD), patent foramen ovale (PFO), or patent ductus arteriosus (PDA). This is a single-use device.
Device Sizes# Type, Value, Unit table Type Value Unit Catheter Gauge 10 French Device Size Text, specify 0 Outer Diameter 15 Millimeter
Regulatory Flags# DUNS number 967358115 Device count 1 Serial number true Manufacturing date on label 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
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