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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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SAPIEN 3 Ultra System - 00690103207828

SAPIEN 3 Ultra valve with Commander delivery System
Edwards Lifesciences LLC
9750CM23
In Commercial Distribution

  • 00690103207828 ()

  • Outer Diameter: 23.0000 Millimeter
9750CM23A

  • Aortic transcatheter heart valve bioprosthesis, stent-like framework
  • Mitral transcatheter heart valve bioprosthesis

Proclaim™ - 05415067023254

Implantable Pulse Generator
ST. JUDE MEDICAL, INC.
3667
In Commercial Distribution

  • 05415067023254 ()
3667

  • Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable

Proclaim™ - 05415067023247

Implantable Pulse Generator
ST. JUDE MEDICAL, INC.
3665
In Commercial Distribution

  • 05415067023247 ()
3665

  • Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable

St. Jude Medical Infinity™ - 05415067020864

8CH Flex Extn, 90 cm
ST. JUDE MEDICAL, INC.
DBS System
In Commercial Distribution

  • 05415067020864 ()
6373

  • Deep brain electrical stimulation system

St. Jude Medical Infinity™ - 05415067020857

8CH Flex Extn, 60 cm
ST. JUDE MEDICAL, INC.
DBS System
In Commercial Distribution

  • 05415067020857 ()
6372

  • Deep brain electrical stimulation system

St. Jude Medical Infinity™ - 05415067020703

8CH Directional Lead, 40 cm, 1.5
ST. JUDE MEDICAL, INC.
DBS System
In Commercial Distribution

  • 05415067020703 ()
6181

  • Deep brain electrical stimulation system

St. Jude Medical Infinity™ - 05415067020697

8CH Directional Lead, 40 cm, 1.5
ST. JUDE MEDICAL, INC.
DBS System
In Commercial Distribution

  • 05415067020697 ()
6173

  • Deep brain electrical stimulation system

St. Jude Medical Infinity™ - 05415067020680

8CH Directional Lead, 40 cm, 0.5
ST. JUDE MEDICAL, INC.
DBS System
In Commercial Distribution

  • 05415067020680 ()
6172

  • Deep brain electrical stimulation system

St. Jude Medical Infinity™ - 05415067020673

8CH Directional Lead, 40 cm, 0.5
ST. JUDE MEDICAL, INC.
DBS System
In Commercial Distribution

  • 05415067020673 ()
6180

  • Deep brain electrical stimulation system

St. Jude Medical Infinity™ - 05415067020666

8CH Directional Lead, 30 cm, 1.5
ST. JUDE MEDICAL, INC.
DBS System
In Commercial Distribution

  • 05415067020666 ()
6171

  • Deep brain electrical stimulation system
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