Home GUDID 05415067033314 Amplatzer™ Talisman™
Primary DI 05415067033314
Brand Amplatzer™ Talisman™
Company ST. JUDE MEDICAL, INC.
Model 9-PFO-2518
Catalog number 9-PFO-2518
Device description PFO Occluder
Published 2021-09-29
Public version status Update
Distribution status 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 05415067033314 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 05415067033314 05415067033314 5415067033314
GMDN Terms# Term, Definition table Term Definition Cardiac 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 Catheter Gauge 8 French Outer Diameter 25 Millimeter
Regulatory Flags# DUNS number 149818952 Device count 1 Lot or batch true Expiration date on label true Other Devices From This Company# 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 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 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 00811806011288 Amplatzer™ ST. JUDE MEDICAL, INC. MLV 2016-11-08
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