Home GUDID 00811806011271 Amplatzer™
Primary DI 00811806011271
Brand Amplatzer™
Company ST. JUDE MEDICAL, INC.
Model PFO Occluder
Catalog number 9-PFO-018
Published 2016-11-08
Public version status Update
Distribution status In Commercial Distribution
MRI safety MR Conditional
Rx true
OTC false
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 00811806011271 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 00811806011271 00811806011271 811806011271 0811806011271
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 Outer Diameter 18 Millimeter
Regulatory Flags# DUNS number 149818952 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label true Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex true Sterilization required before use false 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 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 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 00811806011288 Amplatzer™ ST. JUDE MEDICAL, INC. MLV 2016-11-08 00811806011301 Amplatzer™ ST. JUDE MEDICAL, INC. MLV 2016-11-08 05415067019127 AMPLATZER™ AGA MEDICAL CORPORATION MLV 2015-01-27 05415067019134 AMPLATZER™
AGA MEDICAL CORPORATION MLV 2015-01-27 05415067019141 AMPLATZER™
AGA MEDICAL CORPORATION MLV 2015-01-27 05415067019158 AMPLATZER™
AGA MEDICAL CORPORATION MLV 2015-01-27
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