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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
4200
In Commercial Distribution

  • 00690103166507 ()

  • SURFACE OF THE ANTERIOR LEAFLET, 26 MM
4200M26

  • Mitral annuloplasty ring
EMBOL-X INTRA-AORTIC FILTER WITH DURAFLO COATING
Edwards Lifesciences LLC
EXXLD
In Commercial Distribution

  • 00690103166378 ()

  • ID 35-40 mm (Minimum Aortic Inner Diameter - Maximum Aortic Inner Diameter)
EXXLD

  • Embolic protection filtering guidewire
EMBOL-X INTRA-AORTIC FILTER WITH DURAFLO COATING
Edwards Lifesciences LLC
EXLLD
In Commercial Distribution

  • 00690103166361 ()

  • ID 32-35 mm (Minimum Aortic Inner Diameter - Maximum Aortic Inner Diameter)
EXLLD

  • Embolic protection filtering guidewire
EMBOL-X INTRA-AORTIC FILTER WITH DURAFLO COATING
Edwards Lifesciences LLC
EXMMD
In Commercial Distribution

  • 00690103166354 ()

  • ID 29-32 mm (Minimum Aortic Inner Diameter - Maximum Aortic Inner Diameter)
EXMMD

  • Embolic protection filtering guidewire
EMBOL-X INTRA-AORTIC FILTER WITH DURAFLO COATING
Edwards Lifesciences LLC
EXSSD
In Commercial Distribution

  • 00690103166347 ()

  • ID 26-29 mm (Minimum Aortic Inner Diameter - Maximum Aortic Inner Diameter)
EXSSD

  • Embolic protection filtering guidewire
EMBOL-X INTRA-AORTIC FILTER WITH DURAFLO COATING
Edwards Lifesciences LLC
EXXSD
In Commercial Distribution

  • 00690103166330 ()

  • ID 22-26 mm (Minimum Aortic Inner Diameter - Maximum Aortic Inner Diameter)
EXXSD

  • Embolic protection filtering guidewire
No Description
Edwards Lifesciences LLC
4600
In Commercial Distribution

  • 00690103020571 ()

  • MITRAL ANNULUS DIAMETER, 38 MM FOR TRICUSPID, ANTERIOR OR POSTERIOR LEAFLET DIAMETER, 38 MM
460038MM

  • Mitral/tricuspid annuloplasty ring, open-surgery
No Description
Edwards Lifesciences LLC
4600
In Commercial Distribution

  • 00690103020564 ()

  • MITRAL ANNULUS DIAMENTER, 36 MM FOR TRICUSPID, ANTERIOR OR POSTERIOR LEAFLET DIAMETER, 36 MM
460036MM

  • Mitral/tricuspid annuloplasty ring, open-surgery
No Description
Edwards Lifesciences LLC
4600
In Commercial Distribution

  • 00690103020557 ()

  • MITRAL ANNULUS DIAMENTER, 34 MM FOR TRICUSPID, ANTERIOR OR POSTERIOR LEAFLET DIAMETER, 34 MM
460034MM

  • Mitral/tricuspid annuloplasty ring, open-surgery
No Description
Edwards Lifesciences LLC
4600
In Commercial Distribution

  • 00690103020540 ()

  • MITRAL ANNULUS DIAMENTER, 32 MM FOR TRICUSPID, ANTERIOR OR POSTERIOR LEAFLET DIAMETER, 32 MM
460032MM

  • Mitral/tricuspid annuloplasty ring, open-surgery
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