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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Annuloplasty Ring Sizer Set
ST. JUDE MEDICAL, INC.
SAR-501
In Commercial Distribution

SAR-501

  • Heart valve annulus sizer, reusable
Rigid Saddle Ring Sizer Set
ST. JUDE MEDICAL, INC.
RSAR-507A
In Commercial Distribution

RSAR-507A

  • Heart valve annulus sizer, reusable
Universal II Slittable Inner Catheter (Subselector)
ST. JUDE MEDICAL, INC.
DS2N101-59
In Commercial Distribution

  • 05415067041777 ()

  • Catheter Gauge: 8.0000 French
  • Outer Diameter: 2.4600 Millimeter
  • Length: 59.0000 Centimeter
DS2N101-59

  • Vascular guide-catheter, single-use
Universal II Slittable Inner Catheter (Subselector)
ST. JUDE MEDICAL, INC.
DS2N102-59
In Commercial Distribution

  • 05415067041760 ()

  • Catheter Gauge: 8.0000 French
  • Length: 59.0000 Centimeter
  • Outer Diameter: 2.4600 Millimeter
DS2N102-59

  • Vascular guide-catheter, single-use
Universal II Slittable Inner Catheter (Subselector)
ST. JUDE MEDICAL, INC.
DS2N102-65
In Commercial Distribution

  • 05415067041753 ()

  • Catheter Gauge: 8.0000 French
  • Outer Diameter: 2.4600 Millimeter
  • Length: 65.0000 Centimeter
DS2N102-65

  • Vascular guide-catheter, single-use
Universal II Slittable Inner Catheter (Cannulator)
ST. JUDE MEDICAL, INC.
DS2N103-65
In Commercial Distribution

  • 05415067041746 ()

  • Catheter Gauge: 8.0000 French
  • Length: 65.0000 Centimeter
  • Outer Diameter: 2.4600 Millimeter
DS2N103-65

  • Vascular guide-catheter, single-use
Universal II Slittable Inner Catheter (Subselector)
ST. JUDE MEDICAL, INC.
DS2N101-65
In Commercial Distribution

  • 05415067041739 ()

  • Outer Diameter: 2.4600 Millimeter
  • Length: 65.0000 Centimeter
  • Catheter Gauge: 8.0000 French
DS2N101-65

  • Vascular guide-catheter, single-use
X EP System
ST. JUDE MEDICAL, INC.
ENSITE-SYSTEM-111
In Commercial Distribution

  • 05415067041722 ()
ENSITE-SYSTEM-111

  • Cardiac mapping system
Surface Electrode Kit
ST. JUDE MEDICAL, INC.
EN0020-P
In Commercial Distribution

  • 15415067041712 ()
  • 05415067041715 ()
EN0020-P

  • Cardiac mapping system reference patch
Universal II Slittable Inner Catheter (Cannulator)
ST. JUDE MEDICAL, INC.
DS2N104-65
In Commercial Distribution

  • 05415067041586 ()

  • Catheter Gauge: 8.0000 French
  • Outer Diameter: 2.4600 Millimeter
  • Length: 65.0000 Centimeter
DS2N104-65

  • Vascular guide-catheter, single-use
Universal II Slittable Inner Catheter (Subselector)
ST. JUDE MEDICAL, INC.
DS2N100-65
In Commercial Distribution

  • 05415067041524 ()

  • Catheter Gauge: 8.0000 French
  • Outer Diameter: 2.4600 Millimeter
  • Length: 65.0000 Centimeter
DS2N100-65

  • Vascular guide-catheter, single-use
Universal II Slittable Inner Catheter (Subselector)
ST. JUDE MEDICAL, INC.
DS2N100-59
In Commercial Distribution

  • 05415067041517 ()

  • Length: 59.0000 Centimeter
  • Outer Diameter: 2.4600 Millimeter
  • Catheter Gauge: 8.0000 French
DS2N100-59

  • Vascular guide-catheter, single-use
Peel-Away Introducer
ST. JUDE MEDICAL, INC.
405428
In Commercial Distribution

  • 15415067041477 ()
  • 05415067041470 ()
  • 05415067021045 ()

  • Catheter Gauge: 12.0000 French
  • Length: 14.0000 Centimeter
405428

  • Vascular catheter introduction set, nonimplantable
Peel-Away Introducer
ST. JUDE MEDICAL, INC.
405424
In Commercial Distribution

  • 15415067041453 ()
  • 05415067041456 ()
  • 05414734204972 ()

  • Catheter Gauge: 11.0000 French
  • Length: 14.0000 Centimeter
405424

  • Vascular catheter introduction set, nonimplantable
Peel-Away Introducer
ST. JUDE MEDICAL, INC.
405422
In Commercial Distribution

  • 15415067041439 ()
  • 05415067041432 ()
  • 05415067021038 ()

  • Length: 14.0000 Centimeter
  • Catheter Gauge: 10.5000 French
405422

  • Vascular catheter introduction set, nonimplantable
Peel-Away Introducer
ST. JUDE MEDICAL, INC.
405420
In Commercial Distribution

  • 15415067041415 ()
  • 05415067041418 ()
  • 05414734204934 ()

  • Length: 14.0000 Centimeter
  • Catheter Gauge: 10.0000 French
405420

  • Vascular catheter introduction set, nonimplantable
Peel-Away Introducer
ST. JUDE MEDICAL, INC.
405418
In Commercial Distribution

  • 15415067041392 ()
  • 05415067041395 ()
  • 05415067021021 ()

  • Catheter Gauge: 9.5000 French
  • Length: 14.0000 Centimeter
405418

  • Vascular catheter introduction set, nonimplantable
Peel-Away Introducer
ST. JUDE MEDICAL, INC.
405416
In Commercial Distribution

  • 15415067041378 ()
  • 05415067041371 ()
  • 05414734204897 ()

  • Catheter Gauge: 9.0000 French
  • Length: 14.0000 Centimeter
405416

  • Vascular catheter introduction set, nonimplantable
Peel-Away Introducer
ST. JUDE MEDICAL, INC.
405412
In Commercial Distribution

  • 15415067041354 ()
  • 05415067041357 ()
  • 05414734204873 ()

  • Length: 14.0000 Centimeter
  • Catheter Gauge: 8.0000 French
405412

  • Vascular catheter introduction set, nonimplantable
Peel-Away Introducer
ST. JUDE MEDICAL, INC.
405408
In Commercial Distribution

  • 15415067041330 ()
  • 05415067041333 ()
  • 05414734204859 ()

  • Length: 14.0000 Centimeter
  • Catheter Gauge: 7.0000 French
405408

  • Vascular catheter introduction set, nonimplantable
Peel-Away Introducer
ST. JUDE MEDICAL, INC.
405404
In Commercial Distribution

  • 15415067041316 ()
  • 05415067041319 ()
  • 05415067021014 ()

  • Catheter Gauge: 6.0000 French
  • Length: 14.0000 Centimeter
405404

  • Vascular catheter introduction set, nonimplantable
Peel-Away Introducer
ST. JUDE MEDICAL, INC.
405270
In Commercial Distribution

  • 15415067041293 ()
  • 05415067041296 ()
  • 05414734204729 ()

  • Catheter Gauge: 8.0000 French
  • Length: 23.0000 Centimeter
405270

  • Vascular catheter introduction set, nonimplantable
Peel-Away Introducer
ST. JUDE MEDICAL, INC.
405269
In Commercial Distribution

  • 15415067041279 ()
  • 05415067041272 ()
  • 05414734204705 ()

  • Catheter Gauge: 7.0000 French
  • Length: 23.0000 Centimeter
405269

  • Vascular catheter introduction set, nonimplantable
Peel-Away Introducer
ST. JUDE MEDICAL, INC.
405254
In Commercial Distribution

  • 15415067041255 ()
  • 05415067041258 ()
  • 05414734204590 ()

  • Catheter Gauge: 9.0000 French
  • Length: 23.0000 Centimeter
405254

  • Vascular catheter introduction set, nonimplantable
Peel-Away Introducer
ST. JUDE MEDICAL, INC.
405154
In Commercial Distribution


  • Length: 14.0000 Centimeter
  • Catheter Gauge: 7.0000 French
405154

  • Vascular catheter introduction set, nonimplantable
Peel-Away Introducer
ST. JUDE MEDICAL, INC.
405153
In Commercial Distribution


  • Catheter Gauge: 7.0000 French
  • Length: 14.0000 Centimeter
405153

  • Vascular catheter introduction set, nonimplantable
Peel-Away Introducer
ST. JUDE MEDICAL, INC.
405149
In Commercial Distribution


  • Catheter Gauge: 10.0000 French
  • Length: 14.0000 Centimeter
405149

  • Vascular catheter introduction set, nonimplantable
Peel-Away Introducer
ST. JUDE MEDICAL, INC.
405147
In Commercial Distribution


  • Length: 14.0000 Centimeter
  • Catheter Gauge: 9.0000 French
405147

  • Vascular catheter introduction set, nonimplantable
Peel-Away Introducer
ST. JUDE MEDICAL, INC.
405146
In Commercial Distribution


  • Catheter Gauge: 8.5000 French
  • Length: 14.0000 Centimeter
405146

  • Vascular catheter introduction set, nonimplantable
Peel-Away Introducer
ST. JUDE MEDICAL, INC.
405145
In Commercial Distribution


  • Length: 14.0000 Centimeter
  • Catheter Gauge: 8.0000 French
405145

  • Vascular catheter introduction set, nonimplantable
Peel-Away Introducer
ST. JUDE MEDICAL, INC.
405144
In Commercial Distribution

  • 15415067041095 ()
  • 05415067041098 ()
  • 05414734204347 ()

  • Length: 14.0000 Centimeter
  • Catheter Gauge: 16.0000 French
405144

  • Vascular catheter introduction set, nonimplantable
Peel-Away Introducer
ST. JUDE MEDICAL, INC.
405136
In Commercial Distribution

  • 15415067041071 ()
  • 05415067041074 ()
  • 05414734204323 ()

  • Catheter Gauge: 14.0000 French
  • Length: 14.0000 Centimeter
405136

  • Vascular catheter introduction set, nonimplantable
Peel-Away Introducer
ST. JUDE MEDICAL, INC.
405129
In Commercial Distribution

  • 15415067041057 ()
  • 05415067041050 ()
  • 05415067020970 ()

  • Catheter Gauge: 8.0000 French
  • Length: 14.0000 Centimeter
405129

  • Vascular catheter introduction set, nonimplantable
Peel-Away Introducer
ST. JUDE MEDICAL, INC.
405128
In Commercial Distribution

  • 15415067041033 ()
  • 05415067041036 ()
  • 05415067020963 ()

  • Catheter Gauge: 12.0000 French
  • Length: 14.0000 Centimeter
405128

  • Vascular catheter introduction set, nonimplantable
Peel-Away Introducer
ST. JUDE MEDICAL, INC.
405124
In Commercial Distribution

  • 15415067041019 ()
  • 05415067041012 ()
  • 05414734204248 ()

  • Catheter Gauge: 11.0000 French
  • Length: 14.0000 Centimeter
405124

  • Vascular catheter introduction set, nonimplantable
Peel-Away Introducer
ST. JUDE MEDICAL, INC.
405122
In Commercial Distribution

  • 15415067040999 ()
  • 05415067040992 ()
  • 05414734204224 ()

  • Length: 14.0000 Centimeter
  • Catheter Gauge: 10.5000 French
405122

  • Vascular catheter introduction set, nonimplantable
Peel-Away Introducer
ST. JUDE MEDICAL, INC.
405120
In Commercial Distribution

  • 15415067040975 ()
  • 05415067040978 ()
  • 05414734204200 ()

  • Length: 14.0000 Centimeter
  • Catheter Gauge: 10.0000 French
405120

  • Vascular catheter introduction set, nonimplantable
Peel-Away Introducer
ST. JUDE MEDICAL, INC.
405118
In Commercial Distribution

  • 15415067040937 ()
  • 05415067040930 ()
  • 05414734204163 ()

  • Catheter Gauge: 9.5000 French
  • Length: 14.0000 Centimeter
405118

  • Vascular catheter introduction set, nonimplantable
Peel-Away Introducer
ST. JUDE MEDICAL, INC.
405108
In Commercial Distribution

  • 15415067040876 ()
  • 05415067040879 ()
  • 05414734204101 ()

  • Length: 14.0000 Centimeter
  • Catheter Gauge: 7.0000 French
405108

  • Vascular catheter introduction set, nonimplantable
X EP System Software Upgrade
ST. JUDE MEDICAL, INC.
ENSITE-SW-1.1.1
In Commercial Distribution

  • 05415067040770 ()
ENSITE-SW-1.1.1

  • Cardiac mapping system application software
Leadless Pacemaker
ST. JUDE MEDICAL, INC.
LSP202V
In Commercial Distribution

  • 05415067040725 ()
LSP202V

  • Intracardiac pacemaker
MerlinAtHome Software
ST. JUDE MEDICAL, INC.
EX2000
In Commercial Distribution

  • 05415067040404 ()
EX2000

  • Transtelephonic implantable pacemaker analysis system
Delivery Catheter
ST. JUDE MEDICAL, INC.
LSCD201
In Commercial Distribution

  • 05415067038487 ()
LSCD201

  • Vascular guide-catheter, single-use
X EP System Wave Speed Map Software License
ST. JUDE MEDICAL, INC.
ENSITE-WS-01
In Commercial Distribution

  • 05415067038111 ()
ENSITE-WS-01

  • Cardiac mapping system application software
Software License
ST. JUDE MEDICAL, INC.
ENSITE-D-WS-01
In Commercial Distribution

  • 05415067038098 ()
ENSITE-D-WS-01

  • Cardiac mapping system application software
X EP System Omnipolar Technology Data Export Software License
ST. JUDE MEDICAL, INC.
ENSITE-OTEXPORT-01
In Commercial Distribution

  • 05415067037770 ()
ENSITE-OTEXPORT-01

  • Cardiac mapping system application software
Software Upgrade
ST. JUDE MEDICAL, INC.
ENSITE-SW-1.1
In Commercial Distribution

  • 05415067037763 ()
ENSITE-SW-1.1

  • Cardiac mapping system application software
X EP System Display Workstation
ST. JUDE MEDICAL, INC.
ENSITE-R-DWS-1.1
In Commercial Distribution

  • 05415067037756 ()
ENSITE-R-DWS-1.1

  • Cardiac mapping system
X EP System LiveView Dynamic Display Demo Software License
ST. JUDE MEDICAL, INC.
ENSITE-D-LV-01
In Commercial Distribution

  • 05415067037749 ()
ENSITE-D-LV-01

  • Cardiac mapping system application software
X EP System Live Export Software License
ST. JUDE MEDICAL, INC.
ENSITE-LE-01
In Commercial Distribution

  • 05415067037732 ()
ENSITE-LE-01

  • Cardiac mapping system application software
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