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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Vessel Dilator
ST. JUDE MEDICAL, INC.
405536
In Commercial Distribution


  • Catheter Gauge: 14.0000 French
  • Length: 19.0000 Centimeter
405536

  • Vascular dilator, single-use
Vessel Dilator
ST. JUDE MEDICAL, INC.
405528
In Commercial Distribution


  • Catheter Gauge: 12.0000 French
  • Length: 19.0000 Centimeter
405528

  • Vascular dilator, single-use
Vessel Dilator
ST. JUDE MEDICAL, INC.
405524
In Commercial Distribution


  • Catheter Gauge: 11.0000 French
  • Length: 19.0000 Centimeter
405524

  • Vascular dilator, single-use
Vessel Dilator
ST. JUDE MEDICAL, INC.
405522
In Commercial Distribution


  • Length: 19.0000 Centimeter
  • Catheter Gauge: 4.0000 French
405522

  • Vascular dilator, single-use
Vessel Dilator
ST. JUDE MEDICAL, INC.
405520
In Commercial Distribution


  • Length: 19.0000 Centimeter
  • Catheter Gauge: 10.0000 French
405520

  • Vascular dilator, single-use
Vessel Dilator
ST. JUDE MEDICAL, INC.
405516
In Commercial Distribution


  • Length: 19.0000 Centimeter
  • Catheter Gauge: 9.0000 French
405516

  • Vascular dilator, single-use
Vessel Dilator
ST. JUDE MEDICAL, INC.
405512
In Commercial Distribution


  • Catheter Gauge: 8.0000 French
  • Length: 19.0000 Centimeter
405512

  • Vascular dilator, single-use
Vessel Dilator
ST. JUDE MEDICAL, INC.
405508
In Commercial Distribution


  • Length: 19.0000 Centimeter
  • Catheter Gauge: 7.0000 French
405508

  • Vascular dilator, single-use
Vessel Dilator
ST. JUDE MEDICAL, INC.
405504
In Commercial Distribution


  • Length: 19.0000 Centimeter
  • Catheter Gauge: 6.0000 French
405504

  • Vascular dilator, single-use
Vessel Dilator
ST. JUDE MEDICAL, INC.
405500
In Commercial Distribution


  • Length: 19.0000 Centimeter
  • Catheter Gauge: 5.0000 French
405500

  • Vascular dilator, single-use
X EP System Advanced Mapping Software License
ST. JUDE MEDICAL, INC.
ENSITE-AM-2.0
In Commercial Distribution

  • 05415067042507 ()
ENSITE-AM-2.0

  • Cardiac mapping system application software
X EP System Advanced Mapping Demo Software License
ST. JUDE MEDICAL, INC.
ENSITE-D-AM-2.0
In Commercial Distribution

  • 05415067042477 ()
ENSITE-D-AM-2.0

  • Cardiac mapping system application software
EP System Software Upgrade
ST. JUDE MEDICAL, INC.
ENSITE-SW-2.0
In Commercial Distribution

  • 05415067042460 ()
ENSITE-SW-2.0

  • Cardiac mapping system application software
Software Upgrade Kit
ST. JUDE MEDICAL, INC.
H800014
In Commercial Distribution

  • 05415067042385 ()
H800014

  • Cardiac catheterization monitoring system
Software Upgrade Kit
ST. JUDE MEDICAL, INC.
H800013
In Commercial Distribution

  • 05415067042378 ()
H800013

  • Cardiac catheterization monitoring system
Software Upgrade Kit
ST. JUDE MEDICAL, INC.
H800015
In Commercial Distribution

  • 05415067042361 ()
H800015

  • Cardiac catheterization monitoring system
Mechanical Heart Valve Sizer Set
ST. JUDE MEDICAL, INC.
907
In Commercial Distribution

907

  • Heart valve annulus sizer, reusable
Mechanical Heart Valve Sizer Set
ST. JUDE MEDICAL, INC.
905
In Commercial Distribution

905

  • Heart valve annulus sizer, reusable
Mechanical Heart Valve Leaflet Tester
ST. JUDE MEDICAL, INC.
LT100
In Commercial Distribution

  • 15415067042313 ()
  • 05415067042316 ()
  • 05415067004772 ()
LT100

  • Heart valve prosthesis tester, single-use
Replacement Holder/Rotators
ST. JUDE MEDICAL, INC.
M-RHR
In Commercial Distribution

M-RHR

  • Heart valve prosthesis holder, single-use
Replacement Holder/Rotators
ST. JUDE MEDICAL, INC.
AG-RHR
In Commercial Distribution

AG-RHR

  • Heart valve prosthesis holder, single-use
Replacement Holder/Rotators
ST. JUDE MEDICAL, INC.
AHP-RHR
In Commercial Distribution

AHP-RHR

  • Heart valve prosthesis holder, single-use
Replacement Holder/Rotators
ST. JUDE MEDICAL, INC.
A-RHR
In Commercial Distribution

A-RHR

  • Heart valve prosthesis holder, single-use
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
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