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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Mechanical Heart Valve
ST. JUDE MEDICAL, INC.
31AJ-501
In Commercial Distribution


  • Outer Diameter: 31.0000 Millimeter
31AJ-501

  • Aortic bi-leaflet mechanical heart valve prosthesis
Mechanical Heart Valve
ST. JUDE MEDICAL, INC.
29AJ-501
In Commercial Distribution


  • Outer Diameter: 29.0000 Millimeter
29AJ-501

  • Aortic bi-leaflet mechanical heart valve prosthesis
Mechanical Heart Valve
ST. JUDE MEDICAL, INC.
27AJ-501
In Commercial Distribution


  • Outer Diameter: 27.0000 Millimeter
27AJ-501

  • Aortic bi-leaflet mechanical heart valve prosthesis
Mechanical Heart Valve
ST. JUDE MEDICAL, INC.
25AJ-501
In Commercial Distribution


  • Outer Diameter: 25.0000 Millimeter
25AJ-501

  • Aortic bi-leaflet mechanical heart valve prosthesis
Mechanical Heart Valve
ST. JUDE MEDICAL, INC.
23AJ-501
In Commercial Distribution


  • Outer Diameter: 23.0000 Millimeter
23AJ-501

  • Aortic bi-leaflet mechanical heart valve prosthesis
Mechanical Heart Valve
ST. JUDE MEDICAL, INC.
21AJ-501
In Commercial Distribution


  • Outer Diameter: 21.0000 Millimeter
21AJ-501

  • Aortic bi-leaflet mechanical heart valve prosthesis
Mechanical Heart Valve
ST. JUDE MEDICAL, INC.
19AJ-501
In Commercial Distribution


  • Outer Diameter: 19.0000 Millimeter
19AJ-501

  • Aortic bi-leaflet mechanical heart valve prosthesis
HP Mechanical Heart Valve
ST. JUDE MEDICAL, INC.
15AHPJ-505
In Commercial Distribution


  • Outer Diameter: 15.0000 Millimeter
15AHPJ-505

  • Aortic bi-leaflet mechanical heart valve prosthesis
Mechanical Heart Valve
ST. JUDE MEDICAL, INC.
21AGFN-756
In Commercial Distribution


  • Outer Diameter: 21.0000 Millimeter
21AGFN-756

  • Aortic bi-leaflet mechanical heart valve prosthesis
Mechanical Heart Valve
ST. JUDE MEDICAL, INC.
19AGFN-756
In Commercial Distribution


  • Outer Diameter: 19.0000 Millimeter
19AGFN-756

  • Aortic bi-leaflet mechanical heart valve prosthesis
Repositioning Sleeve
ST. JUDE MEDICAL, INC.
406503
In Commercial Distribution


  • Length: 60.0000 Centimeter
406503

  • Cardiovascular catheter sheath
Repositioning Sleeve
ST. JUDE MEDICAL, INC.
406502
In Commercial Distribution


  • Length: 30.0000 Centimeter
406502

  • Cardiovascular catheter sheath
Repositioning Sleeve
ST. JUDE MEDICAL, INC.
406501
In Commercial Distribution


  • Length: 60.0000 Centimeter
406501

  • Cardiovascular catheter sheath
Repositioning Sleeve
ST. JUDE MEDICAL, INC.
406500
In Commercial Distribution


  • Length: 30.0000 Centimeter
406500

  • Cardiovascular catheter sheath
Vessel Dilator
ST. JUDE MEDICAL, INC.
405545
In Commercial Distribution


  • Catheter Gauge: 4.0000 French
  • Length: 15.0000 Centimeter
405545

  • Vascular dilator, single-use
Vessel Dilator
ST. JUDE MEDICAL, INC.
405544
In Commercial Distribution


  • Catheter Gauge: 16.0000 French
  • Length: 19.0000 Centimeter
405544

  • Vascular dilator, single-use
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
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