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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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Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (6mm x 40mm) x 80cm
Spectranetics Corporation
AB35SX060040080
In Commercial Distribution

  • 00813132023140 ()

  • Balloon Diameter: 6 Millimeter
  • Balloon Length: 40 Millimeter
  • Catheter Length: 80 Centimeter
AB35SX060040080

  • Peripheral angioplasty balloon catheter, drug-coated
Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (5mm x 120mm) x 80cm
Spectranetics Corporation
AB35SX050120080
In Commercial Distribution

  • 00813132023133 ()

  • Balloon Diameter: 5 Millimeter
  • Balloon Length: 120 Millimeter
  • Catheter Length: 80 Centimeter
AB35SX050120080

  • Peripheral angioplasty balloon catheter, drug-coated
Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (5mm x 80mm) x 80cm
Spectranetics Corporation
AB35SX050080080
In Commercial Distribution

  • 00813132023126 ()

  • Balloon Diameter: 5 Millimeter
  • Balloon Length: 80 Millimeter
  • Catheter Length: 80 Centimeter
AB35SX050080080

  • Peripheral angioplasty balloon catheter, drug-coated
Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (5mm x 40mm) x 80cm
Spectranetics Corporation
AB35SX050040080
In Commercial Distribution

  • 00813132023119 ()

  • Balloon Diameter: 5 Millimeter
  • Balloon Length: 40 Millimeter
  • Catheter Length: 80 Centimeter
AB35SX050040080

  • Peripheral angioplasty balloon catheter, drug-coated
Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (4mm x 120mm) x 80cm
Spectranetics Corporation
AB35SX040120080
In Commercial Distribution

  • 00813132023102 ()

  • Balloon Diameter: 4 Millimeter
  • Balloon Length: 120 Millimeter
  • Catheter Length: 80 Centimeter
AB35SX040120080

  • Peripheral angioplasty balloon catheter, drug-coated
Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (4mm x 80mm) x 80cm
Spectranetics Corporation
AB35SX040080080
In Commercial Distribution

  • 00813132023096 ()

  • Balloon Diameter: 4 Millimeter
  • Balloon Length: 80 Millimeter
  • Catheter Length: 80 Centimeter
AB35SX040080080

  • Peripheral angioplasty balloon catheter, drug-coated
Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (4mm x 40mm) x 80cm
Spectranetics Corporation
AB35SX040040080
In Commercial Distribution

  • 00813132023089 ()

  • Balloon Diameter: 4 Millimeter
  • Balloon Length: 40 Millimeter
  • Catheter Length: 80 Centimeter
AB35SX040040080

  • Peripheral angioplasty balloon catheter, drug-coated
SurVeil DCB 7.0mm x 100mm x 135cm
Surmodics, Inc.
SRV03513507010
In Commercial Distribution

  • 00812339030548 ()

  • Balloon Diameter: 7 Millimeter
  • Balloon Length: 100 Millimeter
  • Catheter Length: 135 Centimeter


  • Peripheral angioplasty balloon catheter, drug-coated
SurVeil DCB 7.0mm x 40mm x 135cm
Surmodics, Inc.
SRV03513507040
In Commercial Distribution

  • 00812339030517 ()

  • Balloon Diameter: 7 Millimeter
  • Balloon Length: 40 Millimeter
  • Catheter Length: 135 Centimeter


  • Peripheral angioplasty balloon catheter, drug-coated
SurVeil DCB 6.0mm x 120mm x 135cm
Surmodics, Inc.
SRV03513506012
In Commercial Distribution

  • 00812339030494 ()

  • Balloon Diameter: 6 Millimeter
  • Balloon Length: 120 Millimeter
  • Catheter Length: 135 Centimeter


  • Peripheral angioplasty balloon catheter, drug-coated
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