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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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Edwards Lifesciences LLC
2700TFX
In Commercial Distribution

  • 00690103177169 ()

  • MOUNTING DIAMETER (ANNULUS), 19 MILLIMETER
2700TFX19MM

  • Aortic open-surgery heart valve bioprosthesis
PRESEP OXIMETRY CATHETER 8.5F 16CM W/O THROMBOSHIELD
Edwards Lifesciences LLC
X3816S
Not in Commercial Distribution

  • 00690103176810 ()

  • Exterior Diameter: 8.5 F (2.8 mm), Usable Length: 16 cm, Number of Lumens: 3, Recommended Guidewire Size: 0.032" (0.81 mm)
X3816S

  • Oximeter catheter, single-use
ARTERIAL EMBOLECTOMY CATHETER WITH GATE VALVE 2F 45CM
Edwards Lifesciences LLC
12GV0402F
In Commercial Distribution

  • 00690103176186 ()

  • CATHETER FRENCH SIZE: 2F (0.67MM), USABLE LENGTH: 45 CM
12GV0402F

  • Thrombectomy balloon catheter
CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL AORTIC BIOPROSTHESIS
Edwards Lifesciences LLC
3300TFX
In Commercial Distribution

  • 00690103176179 ()

  • STENT DIAMETER, (TAD), 29 MILLIMETER
3300TFX29MM

  • Aortic open-surgery heart valve bioprosthesis
CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL AORTIC BIOPROSTHESIS
Edwards Lifesciences LLC
3300TFX
In Commercial Distribution

  • 00690103176162 ()

  • STENT DIAMETER, (TAD), 27 MILLIMETER
3300TFX27MM

  • Aortic open-surgery heart valve bioprosthesis
CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL AORTIC BIOPROSTHESIS
Edwards Lifesciences LLC
3300TFX
In Commercial Distribution

  • 00690103176155 ()

  • STENT DIAMETER, (TAD), 25 MILLIMETER
3300TFX25MM

  • Aortic open-surgery heart valve bioprosthesis
CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL AORTIC BIOPROSTHESIS
Edwards Lifesciences LLC
3300TFX
In Commercial Distribution

  • 00690103176148 ()

  • STENT DIAMETER, (TAD), 23 MILLIMETER
3300TFX23MM

  • Aortic open-surgery heart valve bioprosthesis
CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL AORTIC BIOPROSTHESIS
Edwards Lifesciences LLC
3300TFX
In Commercial Distribution

  • 00690103176131 ()

  • STENT DIAMETER, (TAD), 21 MILLIMETER
3300TFX21MM

  • Aortic open-surgery heart valve bioprosthesis
CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL AORTIC BIOPROSTHESIS
Edwards Lifesciences LLC
3300TFX
In Commercial Distribution

  • 00690103176124 ()

  • STENT DIAMETER, (TAD), 19 MILLIMETER
3300TFX19MM

  • Aortic open-surgery heart valve bioprosthesis
Single Stage Venous Return Cannula
Edwards Lifesciences LLC
VCS02890
In Commercial Distribution

  • 00690103175851 ()
  • 50690103175856 ()

  • 28 Fr. (9.3 mm) x 35 cm (14")
VCS02890

  • Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, drainage
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