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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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.
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.
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.
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.
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.
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.
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.
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.
405128
In Commercial Distribution

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

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

  • Vascular catheter introduction set, nonimplantable
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 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 Live Export Software License
ST. JUDE MEDICAL, INC.
ENSITE-LE-01
In Commercial Distribution

  • 05415067037732 ()
ENSITE-LE-01

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

  • 05415067037718 ()
ENSITE-LV-01

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

  • 05415067037695 ()
ENSITE-D-OT-01

  • Cardiac mapping system application software
Monitor Cable
ST. JUDE MEDICAL, INC.
C12849
In Commercial Distribution

  • 05415067037572 ()
C12849

  • Electrical-only medical device connection cable, reusable
Imaging System
ST. JUDE MEDICAL, INC.
1014932
In Commercial Distribution

  • 05415067037558 ()
1014932

  • Coronary optical coherence tomography system
Mobile Next
ST. JUDE MEDICAL, INC.
1014937
In Commercial Distribution

  • 05415067036629 ()
1014937

  • Coronary optical coherence tomography system
Steerable Delivery Sheath
ST. JUDE MEDICAL, INC.
ASDS-14F-075
Not in Commercial Distribution

  • 05415067036025 ()

  • Length: 75.0000 Centimeter
ASDS-14F-075

  • Cardiac occluder delivery kit
Software Installation
ST. JUDE MEDICAL, INC.
H800009
In Commercial Distribution

  • 05415067035608 ()
H800009

  • Cardiac catheterization monitoring system
Software Installation
ST. JUDE MEDICAL, INC.
H800010
In Commercial Distribution

  • 05415067035578 ()
H800010

  • Cardiac catheterization monitoring system
Software Installation
ST. JUDE MEDICAL, INC.
H800011
In Commercial Distribution

  • 05415067035561 ()
H800011

  • Cardiac catheterization monitoring system
Slitter
ST. JUDE MEDICAL, INC.
DS3A001
In Commercial Distribution

  • 05415067035028 ()
DS3A001

  • Intravascular catheter slitter
Software Installation
ST. JUDE MEDICAL, INC.
H702701
In Commercial Distribution

  • 05415067035004 ()
H702701

  • Cardiac mapping system application software
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