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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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CARPENTIER-EDWARDS PHYSIO II ANNULOPLASTY RING
Edwards Lifesciences LLC
5200M28
In Commercial Distribution

  • 00690103180190 ()

  • MEASUREMENT OF THE INTER-COMMISSURAL DISTANCE AND HEIGHT AND/OR SURFACE AREA OF THE ANTERIOR LEAFLET 28 MILLIMETERS
5200M28

  • Mitral/tricuspid annuloplasty ring, open-surgery
No Description
Edwards Lifesciences LLC
5200
In Commercial Distribution

  • 00690103180183 ()

  • MEASUREMENT OF THE INTER-COMMISSURAL DISTANCE AND HEIGHT AND/OR SURFACE AREA OF THE ANTERIOR LEAFLET 26 MILLIMETERS
5200M26

  • Mitral/tricuspid annuloplasty ring, open-surgery
No Description
Edwards Lifesciences LLC
5200
In Commercial Distribution

  • 00690103180176 ()

  • MEASUREMENT OF THE INTER-COMMISSURAL DISTANCE AND HEIGH AND/OR SURFACE AREA OF THE ANTERIOR LEAFLET 24 MILLIMETERS
5200M24

  • Mitral/tricuspid annuloplasty ring, open-surgery
Femoral Venous Cannula
Edwards Lifesciences LLC
FTV024
In Commercial Distribution

  • 00690103180138 ()

  • 24 Fr. (8.0 mm) x 68 cm (26.8")
FTV024

  • Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, drainage
  • Cardiopulmonary bypass cannula, femoral
Femoral Venous Cannula
Edwards Lifesciences LLC
FTV020
In Commercial Distribution

  • 00690103180121 ()

  • 20 Fr. (6.7 mm) x 55 cm (21.6")
FTV020

  • Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, drainage
  • Cardiopulmonary bypass cannula, femoral
EZ GLIDE Aortic Cannula
Edwards Lifesciences LLC
EZS21QTA
In Commercial Distribution

  • 00690103179767 ()
  • 50690103179762 ()

  • 21 Fr. (7.0 mm) X 35 cm (14")
EZS21QTA

  • Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, return
No Description
Edwards Lifesciences LLC
9100CR26
In Commercial Distribution

  • 00690103177992 ()

  • 26 MILIMETER DIAMETER CORRELATES WITH EXPANDED VALVE SIZE
9100CR26

  • Basic crimper
No Description
Edwards Lifesciences LLC
9100CR23
In Commercial Distribution

  • 00690103177985 ()

  • 23 MILIMETER DIAMETER CORRELATES WITH EXPANDED VALVE SIZE
9100CR23

  • Basic crimper
FOGARTY THRU-LUMEN EMBOLECTOMY CATHETER 3F 120CM
Edwards Lifesciences LLC
12TLW1203F
In Commercial Distribution

  • 00690103177657 ()

  • CATHETER FRENCH SIZE: 3F (1.00MM), USABLE LENGTH: 120 CM, MINIMUM INTRODUCER SIZE: 4.5F (1.50MM)
12TLW1203F

  • Thrombectomy balloon catheter
No Description
Edwards Lifesciences LLC
2800TFX
In Commercial Distribution

  • 00690103177275 ()

  • MOUNTING DIAMETER (ANNULUS), 29 MILLIMETER
2800TFX29MM

  • Aortic open-surgery heart valve bioprosthesis
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