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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Therapy™ - 05415067004543

Ablation Catheter
IRVINE BIOMEDICAL, INC.
Cool Path™ DUO SP
Not in Commercial Distribution

  • 05415067004543 ()

  • Catheter Gauge: 7 French
A700454

  • Cardiac radio-frequency ablation system catheter

Cool Path™ - 05415067002440

Ablation Catheter
IRVINE BIOMEDICAL, INC.
A700244
In Commercial Distribution

  • 05415067002440 ()

  • Catheter Gauge: 8 French
A700244

  • Cardiac radio-frequency ablation system catheter

Cool Path™ - 05415067002433

Ablation Catheter
IRVINE BIOMEDICAL, INC.
A700243
In Commercial Distribution

  • 05415067002433 ()

  • Catheter Gauge: 8 French
A700243

  • Cardiac radio-frequency ablation system catheter

Cool Path™ - 05415067002426

Ablation Catheter
IRVINE BIOMEDICAL, INC.
A700242
In Commercial Distribution

  • 05415067002426 ()

  • Catheter Gauge: 8 French
A700242

  • Cardiac radio-frequency ablation system catheter

Cool Path™ - 05415067002419

Abalation Catheter
IRVINE BIOMEDICAL, INC.
A700241
In Commercial Distribution

  • 05415067002419 ()

  • Catheter Gauge: 8 French
A700241

  • Cardiac radio-frequency ablation system catheter

SJM™ Masters Series Hemashield™ - 05414734023825

St. Jude Medical Valved Graft Rotatable Mechanical Heart Valve
ST. JUDE MEDICAL, INC.
CAVGJ-514 00
Not in Commercial Distribution

  • 05414734023825 ()

  • Outer Diameter: 29 Millimeter
29CAVGJ-514 00

  • Aortic bi-leaflet mechanical heart valve prosthesis/biologic-polymer aorta graft

SJM™ Masters Series Hemashield™ - 05414734023818

St. Jude Medical Valved Graft Rotatable Mechanical Heart Valve
ST. JUDE MEDICAL, INC.
CAVGJ-514 00
Not in Commercial Distribution

  • 05414734023818 ()

  • Outer Diameter: 21 Millimeter
21CAVGJ-514 00

  • Aortic bi-leaflet mechanical heart valve prosthesis/biologic-polymer aorta graft

SJM™ Masters Series Hemashield™ - 05414734023795

St. Jude Medical Aortic Valved Graft Mechanical Heart Valve
ST. JUDE MEDICAL, INC.
23CAVGJ-514 00
Not in Commercial Distribution

  • 05414734023795 ()

  • Outer Diameter: 23 Millimeter
23CAVGJ-514 00

  • Aortic bi-leaflet mechanical heart valve prosthesis/biologic-polymer aorta graft

SJM™ Masters Series Hemashield™ - 05414734023788

St. Jude Medical Valved Graft Rotatable Mechanical Heart Valve
ST. JUDE MEDICAL, INC.
CAVGJ-514 00
Not in Commercial Distribution

  • 05414734023788 ()

  • Outer Diameter: 27 Millimeter
27CAVGJ-514 00

  • Aortic bi-leaflet mechanical heart valve prosthesis/biologic-polymer aorta graft

Safire™ TX - 05414734300155

Ablation Catheter
IRVINE BIOMEDICAL, INC.
402839
In Commercial Distribution

  • 05414734300155 ()

  • Catheter Gauge: 7 French
402839

  • Cardiac radio-frequency ablation system catheter
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