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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™ - 05414734306997

Ablation Catheter
IRVINE BIOMEDICAL, INC.
IBI-83372
In Commercial Distribution

  • 05414734306997 ()

  • Catheter Gauge: 7 French
IBI-83372

  • Cardiac radio-frequency ablation system catheter

Therapy™ - 05414734306980

Ablation Catheter
IRVINE BIOMEDICAL, INC.
IBI-83371
In Commercial Distribution

  • 05414734306980 ()

  • Catheter Gauge: 7 French
IBI-83371

  • Cardiac radio-frequency ablation system catheter

Therapy™ - 05414734306973

Ablation Catheter
IRVINE BIOMEDICAL, INC.
Dual-8™
Not in Commercial Distribution

  • 05414734306973 ()

  • Catheter Gauge: 7 French
IBI-83370

  • Cardiac radio-frequency ablation system catheter

PASCAL - 00690103216981

PASCAL TABLE US COMMERCIAL
Edwards Lifesciences LLC
10000T
In Commercial Distribution

  • 00690103216981 ()
10000TA

  • Cardiac implantation catheter table

PASCAL - 00690103216974

PASCAL SYSTEM - STABILIZER RAIL SYSTEM
Edwards Lifesciences LLC
20000ST
In Commercial Distribution

  • 00690103216974 ()
20000STA

  • Cardiac implantation catheter holder

PASCAL PRECISION - 00690103216967

PASCAL PRECISION SYSTEM - GUIDE SHEATH
Edwards Lifesciences LLC
20000GSA
In Commercial Distribution

  • 00690103216967 ()
20000GSA

  • Heart valve clip

PASCAL - 00690103216950

PASCAL PRECISION SYSTEM – PASCAL ACE IMPLANT SYSTEM
Edwards Lifesciences LLC
20000ISM
In Commercial Distribution

  • 00690103216950 ()
20000ISMA

  • Heart valve clip

PASCAL - 00690103216943

PASCAL PRECISION SYSTEM – IMPLANT SYSTEM
Edwards Lifesciences LLC
20000IS
In Commercial Distribution

  • 00690103216943 ()
20000ISA

  • Heart valve clip

EDWARDS ESHEATH INTRODUCER SET - 00690103193992

No Description
Edwards Lifesciences LLC
916ES
In Commercial Distribution

  • 00690103193992 ()

  • 16F
916ESA

  • Vascular catheter introduction set, nonimplantable
  • Mitral transcatheter heart valve bioprosthesis
  • Aortic transcatheter heart valve bioprosthesis, stent-like framework

EDWARDS ESHEATH INTRODUCER SET - 00690103193985

No Description
Edwards Lifesciences LLC
914ES
In Commercial Distribution

  • 00690103193985 ()

  • 14F
914ESA

  • Vascular catheter introduction set, nonimplantable
  • Mitral transcatheter heart valve bioprosthesis
  • Aortic transcatheter heart valve bioprosthesis, stent-like framework
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