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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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No Description
Edwards Lifesciences LLC
2625
In Commercial Distribution

  • 00690103021554 ()

  • MOUNTING DIAMETER (ANNULUS), 27 MILLIMETER
262527MM

  • Aortic open-surgery heart valve bioprosthesis
No Description
Edwards Lifesciences LLC
2625
In Commercial Distribution

  • 00690103021547 ()

  • MOUNTING DIAMETER (ANNULUS), 25 MILLIMETER
262525MM

  • Aortic open-surgery heart valve bioprosthesis
No Description
Edwards Lifesciences LLC
2625
In Commercial Distribution

  • 00690103021530 ()

  • MOUNTING DIAMETER (ANNULUS), 23 MILLIMETER
262523MM

  • Aortic open-surgery heart valve bioprosthesis
No Description
Edwards Lifesciences LLC
2625
In Commercial Distribution

  • 00690103021523 ()

  • MOUNTING DIAMETER (ANNULUS), 21 MILLIMETER
262521MM

  • Aortic open-surgery heart valve bioprosthesis
No Description
Edwards Lifesciences LLC
2625
In Commercial Distribution

  • 00690103021516 ()

  • MOUNTING DIAMETER (ANNULUS), 19 MILLIMETER
262519MM

  • Aortic open-surgery heart valve bioprosthesis
40mm (Classic) Straight Stent (28mm collar)
Artivion, Inc.
K038895
In Commercial Distribution

  • 00877234001338 ()

  • Catheter Length: 527 Millimeter
  • Aortic Stent Proximal Diameter: 20-35mm
  • Aortic Stent Distal Diameter: 25-35mm
  • Aortic Stent Minimum Length:153mm
  • Aortic Stent Maximum Length: 207mm
  • Stent Collar Diameter: 28mm
AMDS40c

  • Bare-metal aortic stent
40mm – 30mm (Classic) Tapered Stent (28mm collar)
Artivion, Inc.
K038896
In Commercial Distribution

  • 00877234001321 ()

  • Catheter Length: 527 Millimeter
  • Aortic Stent Proximal Diameter: 20-35mm
  • Aortic Stent Distal Diameter: 20-24mm
  • Aortic Stent Minimum Length:159mm
  • Aortic Stent Maximum Length: 203mm
  • Stent Collar Diameter: 28mm
AMDS4030c

  • Bare-metal aortic stent
55mm – 40mm Tapered Stent (32mm collar)
Artivion, Inc.
K039423
In Commercial Distribution

  • 00877234001222 ()

  • Catheter Length: 546 Millimeter
  • Aortic Stent Proximal Diameter: 36-45mm
  • Aortic Stent Distal Diameter: 27-35mm
  • Aortic Stent Minimum Length:185mm
  • Aortic Stent Maximum Length:211mm
  • Stent Collar Diameter: 32mm
AMDS5540

  • Bare-metal aortic stent
40mm – 30mm Tapered Stent (24mm collar)
Artivion, Inc.
K039421
In Commercial Distribution

  • 00877234001208 ()

  • Catheter Length: 527 Millimeter
  • Aortic Stent Proximal Diameter: 20-35mm
  • Aortic Stent Distal Diameter: 20-24mm
  • Aortic Stent Minimum Length:159mm
  • Aortic Stent Maximum Length:203mm
  • Stent Collar Diameter: 24mm
AMDS4030

  • Bare-metal aortic stent
40mm Straight Stent (24mm collar)
Artivion, Inc.
K039420
In Commercial Distribution

  • 00877234001192 ()

  • Catheter Length: 527 Millimeter
  • Aortic Stent Proximal Diameter: 20-35mm
  • Aortic Stent Distal Diameter: 25-35mm
  • Aortic Stent Minimum Length:153mm
  • Aortic Stent Maximum Length:207mm
  • Stent Collar Diameter: 24mm
AMDS40

  • Bare-metal aortic stent
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