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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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Infrapubic Bioflex® Cylinder Set with Pump - Narrow
Coloplast A/S
90-9816INC
In Commercial Distribution

  • 05708932322348 ()

  • Length: 16 Centimeter
90-9816INC

  • Inflatable penile prosthesis
Titan OTR Pump
Coloplast A/S
90-9000KCOTR
In Commercial Distribution

  • 05708932319744 ()
90-9000KCOTR

  • Inflatable penile prosthesis
Pump
Coloplast A/S
90-9000KC
In Commercial Distribution

  • 05708932319621 ()
90-9000KC

  • Inflatable penile prosthesis
Plug
Coloplast A/S
9471S
In Commercial Distribution

  • 05708932987967 ()
9471S

  • Inflatable penile prosthesis
No Description
Coloplast A/S
ES2924
In Commercial Distribution

  • 05708932768177 ()

  • Length: 24 Centimeter
ES2924

  • Inflatable penile prosthesis
No Description
Coloplast A/S
ES2824
In Commercial Distribution

  • 05708932768153 ()

  • Length: 24 Centimeter
ES2824

  • Inflatable penile prosthesis
No Description
Coloplast A/S
ES8924
In Commercial Distribution

  • 05708932768139 ()

  • Length: 24 Centimeter
ES8924

  • Inflatable penile prosthesis
No Description
Coloplast A/S
ES8824
In Commercial Distribution

  • 05708932768115 ()

  • Length: 24 Centimeter
ES8824

  • Inflatable penile prosthesis
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
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