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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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LUTONIX® Drug Coated Balloon - 00801741163456

Lutonix 035 DCB, 7mm x 120mm x 130cm, 5F
LUTONIX, INC.
LX3513071205F
In Commercial Distribution

  • 00801741163456 ()

  • Balloon Length, 120 Millimeter
  • Catheter Length, 130 Centimeter
  • Balloon Diameter, 7 Millimeter
LX3513071205F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741163449

Lutonix 035 DCB, 7mm x 100mm x 130cm, 5F
LUTONIX, INC.
LX3513071005F
In Commercial Distribution

  • 00801741163449 ()

  • Catheter Length, 130 Centimeter
  • Balloon Diameter, 7 Millimeter
  • Balloon Length, 100 Millimeter
LX3513071005F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741163432

Lutonix 035 DCB, 7mm x 80mm x 130cm, 5F
LUTONIX, INC.
LX351307805F
In Commercial Distribution

  • 00801741163432 ()

  • Catheter Length, 130 Centimeter
  • Balloon Length, 80 Millimeter
  • Balloon Diameter, 7 Millimeter
LX351307805F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741163425

Lutonix 035 DCB, 6mm x 220mm x 130cm, 5F
LUTONIX, INC.
LX3513062205F
In Commercial Distribution

  • 00801741163425 ()

  • Balloon Diameter, 6 Millimeter
  • Catheter Length, 130 Centimeter
  • Balloon Length, 220 Millimeter
LX3513062205F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741163418

Lutonix 035 DCB, 5mm x 220mm x 130cm, 5F
LUTONIX, INC.
LX3513052205F
In Commercial Distribution

  • 00801741163418 ()

  • Balloon Length, 220 Millimeter
  • Balloon Diameter, 5 Millimeter
  • Catheter Length, 130 Centimeter
LX3513052205F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741163401

Lutonix 035 DCB, 4mm x 220mm x 130cm, 5F
LUTONIX, INC.
LX3513042205F
In Commercial Distribution

  • 00801741163401 ()

  • Balloon Length, 220 Millimeter
  • Balloon Diameter, 4 Millimeter
  • Catheter Length, 130 Centimeter
LX3513042205F

  • Peripheral angioplasty balloon catheter, drug-coated

Stellarex - 00813132026530

Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (6mm x 200mm) x 80cm
Spectranetics Corporation
AB35SX060200080
In Commercial Distribution

  • 00813132026530 ()

  • Catheter Length: 80 Centimeter
  • Balloon Length: 200 Millimeter
  • Balloon Diameter: 6 Millimeter
AB35SX060200080

  • Peripheral angioplasty balloon catheter, drug-coated

Stellarex - 00813132026462

Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (4mm x 150mm) x 135cm
Spectranetics Corporation
AB35SX040150135
In Commercial Distribution

  • 00813132026462 ()

  • Catheter Length: 135 Centimeter
  • Balloon Length: 150 Millimeter
  • Balloon Diameter: 4 Millimeter
AB35SX040150135

  • Peripheral angioplasty balloon catheter, drug-coated

Stellarex - 00813132026455

Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (4mm x 200mm) x 135cm
Spectranetics Corporation
AB35SX040200135
In Commercial Distribution

  • 00813132026455 ()

  • Catheter Length: 135 Centimeter
  • Balloon Length: 200 Millimeter
  • Balloon Diameter: 4 Millimeter
AB35SX040200135

  • Peripheral angioplasty balloon catheter, drug-coated

SurVeil DCB - 00812339030548

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
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