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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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POLYSITE Implantable Infusion Port with silicone-filled suture holes
PEROUSE MEDICAL
3017SC
Not in Commercial Distribution

  • 13661234011589 ()


  • Vascular port/catheter
POLYSITE Implantable Infusion Port with silicone-filled suture holes
PEROUSE MEDICAL
2016SC
Not in Commercial Distribution

  • 13661234011541 ()


  • Vascular port/catheter
SAPIEN 3 Ultra valve with Commander Delivery System
Edwards Lifesciences LLC
9750CM26
In Commercial Distribution

  • 00690103207835 ()

  • Outer Diameter: 26.0000 Millimeter
9750CM26A

  • Aortic transcatheter heart valve bioprosthesis, stent-like framework
  • Mitral transcatheter heart valve bioprosthesis
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
5.5 mm Eye-Deal Anchor with two #2 Sutures
Tigon Medical LLC
TM-EDAP002-SS
In Commercial Distribution

  • 00850029805854 ()


  • Tendon/ligament bone anchor, non-bioabsorbable
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
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
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
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
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
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