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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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SAPIEN 3 Ultra valve with Commander delivery System
Edwards Lifesciences LLC
9750CM23
In Commercial Distribution

  • 00690103207828 ()

  • Outer Diameter: 23.0000 Millimeter
9750CM23A

  • Aortic transcatheter heart valve bioprosthesis, stent-like framework
  • Mitral transcatheter heart valve bioprosthesis
ACCU-CHEK GUIDE LINK MG/DL 118
Roche Diagnostics Operations, Inc.
08109257002
In Commercial Distribution

  • 00365702702417 ()
08109257002

  • Glucose analyser IVD, home-use
10-8mm x 30mm
SILK ROAD MEDICAL, INC.
FG11815
In Commercial Distribution

  • 00811311021307 ()
SR-100830-TCS

  • Bare-metal carotid artery stent
8-6mm x 30mm
SILK ROAD MEDICAL, INC.
FG11815
In Commercial Distribution

  • 00811311021260 ()
SR-080630-TCS

  • Bare-metal carotid artery stent
7 mm X 30 mm
SILK ROAD MEDICAL, INC.
SR-0730-CS
In Commercial Distribution

  • 00811311020430 ()
SR-0730-CS

  • Bare-metal carotid artery stent
6 mm X 40 mm
SILK ROAD MEDICAL, INC.
SR-0640-CS
In Commercial Distribution

  • 00811311020416 ()
SR-0640-CS

  • Bare-metal carotid artery stent
10-7mm x 40mm
SILK ROAD MEDICAL, INC.
FG11815
In Commercial Distribution

  • 00811311021321 ()
SR-100740-TCS

  • Bare-metal carotid artery stent
10-8mm x 40mm
SILK ROAD MEDICAL, INC.
FG11815
In Commercial Distribution

  • 00811311021314 ()
SR-100840-TCS

  • Bare-metal carotid artery stent
9-7mm x 40mm
SILK ROAD MEDICAL, INC.
FG11815
In Commercial Distribution

  • 00811311021291 ()
SR-090740-TCS

  • Bare-metal carotid artery stent
9-7mm x 30mm
SILK ROAD MEDICAL, INC.
FG11815
In Commercial Distribution

  • 00811311021284 ()
SR-090730-TCS

  • Bare-metal carotid artery stent
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