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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 - 00690103207811

SAPIEN 3 Ultra valve with Commander Delivery System
Edwards Lifesciences LLC
9750CM20
In Commercial Distribution

  • 00690103207811 ()

  • Outer Diameter: 20.0000 Millimeter
9750CM20A

  • Aortic transcatheter heart valve bioprosthesis, stent-like framework

AMS 700 Accessory Kit - 00878953001135

Inflatable Penile Prosthesis with MS Pump Accessory Kit
BOSTON SCIENTIFIC CORPORATION
72401850
In Commercial Distribution

  • 00878953001135 ()


  • Inflatable penile prosthesis

Axium™ - 05415067025654

Programmer Carrying Case For use with Clinical Programmers
ST. JUDE MEDICAL, INC.
MN13500
In Commercial Distribution

  • 05415067025654 ()
MN13500

  • Medical bag

Trifecta™ - 05415067018250

Aortic Pericardial Bioprosthetic Heart Valve with Glide Technology
ST. JUDE MEDICAL, INC.
TFGT-29A
In Commercial Distribution

  • 05415067018250 ()

  • Outer Diameter: 29 Millimeter
TFGT-29A

  • Aortic open-surgery heart valve bioprosthesis

Trifecta™ - 05415067018243

Aortic Pericardial Bioprosthetic Heart Valve with Glide Technology
ST. JUDE MEDICAL, INC.
TFGT-27A
In Commercial Distribution

  • 05415067018243 ()

  • Outer Diameter: 27 Millimeter
TFGT-27A

  • Aortic open-surgery heart valve bioprosthesis

Trifecta™ - 05415067018236

Aortic Pericardial Bioprosthetic Heart Valve with Glide Technology
ST. JUDE MEDICAL, INC.
TFGT-25A
In Commercial Distribution

  • 05415067018236 ()

  • Outer Diameter: 25 Millimeter
TFGT-25A

  • Aortic open-surgery heart valve bioprosthesis

Trifecta™ - 05415067018229

Aortic Pericardial Bioprosthetic Heart Valve with Glide Technology
ST. JUDE MEDICAL, INC.
TFGT-23A
In Commercial Distribution

  • 05415067018229 ()

  • Outer Diameter: 23 Millimeter
TFGT-23A

  • Aortic open-surgery heart valve bioprosthesis

Trifecta™ - 05415067018212

Aortic Pericardial Bioprosthetic Heart Valve with Glide Technology
ST. JUDE MEDICAL, INC.
TFGT-21A
In Commercial Distribution

  • 05415067018212 ()

  • Outer Diameter: 21 Millimeter
TFGT-21A

  • Aortic open-surgery heart valve bioprosthesis

Trifecta™ - 05415067018205

Aortic Pericardial Bioprosthetic Heart Valve with Glide Technology
ST. JUDE MEDICAL, INC.
TFGT-19A
In Commercial Distribution

  • 05415067018205 ()

  • Outer Diameter: 19 Millimeter
TFGT-19A

  • Aortic open-surgery heart valve bioprosthesis

Titan - 05708932323901

Scrotal Bioflex® Cylinder Set with Pump - Narrow
Coloplast A/S
90-9918SNC
In Commercial Distribution

  • 05708932323901 ()

  • Length: 18 Centimeter
90-9918SNC

  • Inflatable penile prosthesis
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