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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OPTISi Next Monitor
ST. JUDE MEDICAL, INC.
1014942
In Commercial Distribution

  • 05415067036728 ()
1014942

  • Coronary optical coherence tomography system
OPTISi Next DOC
ST. JUDE MEDICAL, INC.
1014940
In Commercial Distribution

  • 05415067036704 ()
1014940

  • Coronary optical coherence tomography system
OPTISm Next DOC
ST. JUDE MEDICAL, INC.
1014939
In Commercial Distribution

  • 05415067036681 ()
1014939

  • Coronary optical coherence tomography system
Loading System
ST. JUDE MEDICAL, INC.
NVTR-LS-SM
In Commercial Distribution

  • 05415067036667 ()
NVTR-LS-SM

  • Self-expandable heart valve bioprosthesis collapsing tool, single-use
Loading System
ST. JUDE MEDICAL, INC.
NVTR-LS-LG
In Commercial Distribution

  • 05415067036650 ()
NVTR-LS-LG

  • Self-expandable heart valve bioprosthesis collapsing tool, single-use
Integrated Next
ST. JUDE MEDICAL, INC.
1014938
In Commercial Distribution

  • 05415067036643 ()
1014938

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

  • 05415067036629 ()
1014937

  • Coronary optical coherence tomography system
PRE-CONNECTED PACK
ST. JUDE MEDICAL, INC.
CMAEK00
In Commercial Distribution

  • 05415067036414 ()
CMAEK00

  • Cardiopulmonary bypass system priming set
  • Cardiopulmonary bypass system centrifugal pump
Delivery Catheter
ST. JUDE MEDICAL, INC.
LSCD111
In Commercial Distribution

  • 05415067036384 ()

  • Outer Diameter: 6.8000 Millimeter
  • Length: 105.0000 Centimeter
LSCD111

  • Vascular guide-catheter, single-use
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 Upgrade Kit
ST. JUDE MEDICAL, INC.
H800012
In Commercial Distribution

  • 05415067035615 ()
H800012

  • Cardiac catheterization monitoring system
Software Installation
ST. JUDE MEDICAL, INC.
H800009
In Commercial Distribution

  • 05415067035608 ()
H800009

  • Cardiac catheterization monitoring system
Software Upgrade Kit
ST. JUDE MEDICAL, INC.
H800008
In Commercial Distribution

  • 05415067035592 ()
H800008

  • Cardiac catheterization monitoring system
Software Upgrade Kit
ST. JUDE MEDICAL, INC.
H800007
In Commercial Distribution

  • 05415067035585 ()
H800007

  • 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
Patient Controller App
ST. JUDE MEDICAL, INC.
55500
In Commercial Distribution

  • 05415067034977 ()
55500

  • Multiple active implantable device programmer
Clinician Programmer App
ST. JUDE MEDICAL, INC.
55600
In Commercial Distribution

  • 05415067034960 ()
55600

  • Multiple active implantable device programmer
Introducer Hydrophilic-Coated Introducer Sheath
ST. JUDE MEDICAL, INC.
LSN25501
In Commercial Distribution

  • 05415067034847 ()

  • Catheter Gauge: 25.0000 French
  • Outer Diameter: 8.9000 Millimeter
  • Length: 50.0000 Centimeter
LSN25501

  • Vascular catheter introduction set, nonimplantable
Introducer Hydrophilic-Coated Introducer Sheath
ST. JUDE MEDICAL, INC.
LSN25301
In Commercial Distribution

  • 05415067034823 ()

  • Outer Diameter: 8.9000 Millimeter
  • Catheter Gauge: 25.0000 French
  • Length: 30.0000 Centimeter
LSN25301

  • Vascular catheter introduction set, nonimplantable
Transmitter
ST. JUDE MEDICAL, INC.
EX1150W
In Commercial Distribution

  • 05415067034809 ()
EX1150W

  • Transtelephonic implantable pacemaker analysis system
X EP System Amplifier
ST. JUDE MEDICAL, INC.
ENSITE-AMP-02
In Commercial Distribution

  • 05415067034755 ()
ENSITE-AMP-02

  • Cardiac mapping system
X EP System Amplifier
ST. JUDE MEDICAL, INC.
ENSITE-R-AMP-02
In Commercial Distribution

  • 05415067034748 ()
ENSITE-R-AMP-02

  • Cardiac mapping system
TactiFlex Radiofrequency Cable
ST. JUDE MEDICAL, INC.
TSQ-RF-TFSE-CBL
In Commercial Distribution

  • 05415067034700 ()

  • Length: 2.0000 Meter
TSQ-RF-TFSE-CBL

  • Electrical-only medical device connection cable, reusable
Ablation Catheter
ST. JUDE MEDICAL, INC.
A-TFSE-J
In Commercial Distribution

  • 05415067034694 ()

  • Length: 115.0000 Centimeter
  • Catheter Gauge: 8.0000 French
A-TFSE-J

  • Cardiac radio-frequency ablation system catheter
Ablation Catheter
ST. JUDE MEDICAL, INC.
A-TFSE-F
In Commercial Distribution

  • 05415067034670 ()

  • Catheter Gauge: 8.0000 French
  • Length: 115.0000 Centimeter
A-TFSE-F

  • Cardiac radio-frequency ablation system catheter
Ablation Catheter
ST. JUDE MEDICAL, INC.
A-TFSE-D
In Commercial Distribution

  • 05415067034656 ()

  • Length: 115.0000 Centimeter
  • Catheter Gauge: 8.0000 French
A-TFSE-D

  • Cardiac radio-frequency ablation system catheter
Ablation Catheter
ST. JUDE MEDICAL, INC.
A-TFSE-JJ
In Commercial Distribution

  • 05415067034632 ()

  • Catheter Gauge: 8.0000 French
  • Length: 115.0000 Centimeter
A-TFSE-JJ

  • Cardiac radio-frequency ablation system catheter
Ablation Catheter
ST. JUDE MEDICAL, INC.
A-TFSE-FJ
In Commercial Distribution

  • 05415067034618 ()

  • Catheter Gauge: 8.0000 French
  • Length: 115.0000 Centimeter
A-TFSE-FJ

  • Cardiac radio-frequency ablation system catheter
Radiofrequency Cannula - Straight
ST. JUDE MEDICAL, INC.
SMK-S1510-20
In Commercial Distribution

  • 05415067028808 ()
  • 15415067028805 ()

  • Needle Gauge: 20 Gauge
  • Length: 15 Centimeter
SMK-S1510-20

  • Percutaneous radio-frequency ablation probe cannula, single-use
Radiofrequency Cannula - Straight
ST. JUDE MEDICAL, INC.
SMK-S1010-22
In Commercial Distribution

  • 05415067028792 ()
  • 15415067028799 ()

  • Length: 10 Centimeter
  • Needle Gauge: 22 Gauge
SMK-S1010-22

  • Percutaneous radio-frequency ablation probe cannula, single-use
Radiofrequency Cannula - Straight
ST. JUDE MEDICAL, INC.
SMK-S1010-20
In Commercial Distribution

  • 05415067028785 ()
  • 15415067028782 ()

  • Length: 10 Centimeter
  • Needle Gauge: 20 Gauge
SMK-S1010-20

  • Percutaneous radio-frequency ablation probe cannula, single-use
Radiofrequency Cannula - Straight
ST. JUDE MEDICAL, INC.
SMK-S1005-20
In Commercial Distribution

  • 05415067028778 ()
  • 15415067028775 ()

  • Length: 10 Centimeter
  • Needle Gauge: 20 Gauge
SMK-S1005-20

  • Percutaneous radio-frequency ablation probe cannula, single-use
Radiofrequency Cannula - Straight
ST. JUDE MEDICAL, INC.
SMK-S1002-22
In Commercial Distribution

  • 05415067028761 ()
  • 15415067028768 ()

  • Needle Gauge: 22 Gauge
  • Length: 10 Centimeter
SMK-S1002-22

  • Percutaneous radio-frequency ablation probe cannula, single-use
Radiofrequency Cannula - Curved
ST. JUDE MEDICAL, INC.
SMK-C1510-20
In Commercial Distribution

  • 05415067028754 ()
  • 15415067028751 ()

  • Length: 15 Centimeter
  • Needle Gauge: 20 Gauge
SMK-C1510-20

  • Percutaneous radio-frequency ablation probe cannula, single-use
Radiofrequency Cannula - Curved
ST. JUDE MEDICAL, INC.
SMK-C1010-22
In Commercial Distribution

  • 05415067028747 ()
  • 15415067028744 ()

  • Length: 10 Centimeter
  • Needle Gauge: 22 Gauge
SMK-C1010-22

  • Percutaneous radio-frequency ablation probe cannula, single-use
Radiofrequency Cannula - Curved
ST. JUDE MEDICAL, INC.
SMK-C1010-20
In Commercial Distribution

  • 05415067028730 ()
  • 15415067028737 ()

  • Length: 10 Centimeter
  • Needle Gauge: 20 Gauge
SMK-C1010-20

  • Percutaneous radio-frequency ablation probe cannula, single-use
Radiofrequency Cannula - Curved
ST. JUDE MEDICAL, INC.
SMK-C1010-18
In Commercial Distribution

  • 05415067028723 ()
  • 15415067028720 ()

  • Needle Gauge: 18 Gauge
  • Length: 10 Centimeter
SMK-C1010-18

  • Percutaneous radio-frequency ablation probe cannula, single-use
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