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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® 035 Drug Coated Balloon PTA Catheter .035" 75cm 4x60mm
LUTONIX, INC.
LX3575460
Not in Commercial Distribution

  • 00801741088025 ()

  • Balloon Diameter,4 Millimeter
  • Balloon Length,60 Millimeter
  • Catheter Length,75 Centimeter
LX3575460

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 6x40mm
LUTONIX, INC.
LX3575640
Not in Commercial Distribution

  • 00801741088001 ()

  • Balloon Length,40 Millimeter
  • Catheter Length,75 Centimeter
  • Balloon Diameter,6 Millimeter
LX3575640

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 4x40mm
LUTONIX, INC.
LX3575440
Not in Commercial Distribution

  • 00801741087981 ()

  • Balloon Diameter,4 Millimeter
  • Catheter Length,75 Centimeter
  • Balloon Length,40 Millimeter
LX3575440

  • Peripheral angioplasty balloon catheter, drug-coated
6mm x 200mm x 135cm
Philips Image Guided Therapy Corporation
AB35SX060200135
In Commercial Distribution

  • 00810060550427 ()

  • Balloon Diameter: 6 Millimeter
  • Balloon Length: 200 Millimeter
  • Catheter Length: 135 Centimeter
AB35SX060200135

  • Peripheral angioplasty balloon catheter, drug-coated
6mm x 200mm x 80cm
Philips Image Guided Therapy Corporation
AB35SX060200080
In Commercial Distribution

  • 00810060550410 ()

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

  • Peripheral angioplasty balloon catheter, drug-coated
6mm x 150mm x 135cm
Philips Image Guided Therapy Corporation
AB35SX060150135
In Commercial Distribution

  • 00810060550403 ()

  • Balloon Diameter: 6 Millimeter
  • Balloon Length: 150 Millimeter
  • Catheter Length: 135 Centimeter
AB35SX060150135

  • Peripheral angioplasty balloon catheter, drug-coated
6mm x 150mm x 80cm
Philips Image Guided Therapy Corporation
AB35SX060150080
In Commercial Distribution

  • 00810060550397 ()

  • Balloon Diameter: 6 Millimeter
  • Balloon Length: 150 Millimeter
  • Catheter Length: 80 Centimeter
AB35SX060150080

  • Peripheral angioplasty balloon catheter, drug-coated
6mm x 120mm x 135cm
Philips Image Guided Therapy Corporation
AB35SX060120135
In Commercial Distribution

  • 00810060550380 ()

  • Balloon Diameter: 6 Millimeter
  • Balloon Length: 120 Millimeter
  • Catheter Length: 135 Centimeter
AB35SX060120135

  • Peripheral angioplasty balloon catheter, drug-coated
6mm x 120mm x 80cm
Philips Image Guided Therapy Corporation
AB35SX060120080
In Commercial Distribution

  • 00810060550373 ()

  • Balloon Diameter: 6 Millimeter
  • Balloon Length: 120 Millimeter
  • Catheter Length: 80 Centimeter
AB35SX060120080

  • Peripheral angioplasty balloon catheter, drug-coated
6mm x 100mm x 135cm
Philips Image Guided Therapy Corporation
AB35SX060100135
In Commercial Distribution

  • 00810060550366 ()

  • Balloon Diameter: 6 Millimeter
  • Balloon Length: 100 Millimeter
  • Catheter Length: 135 Centimeter
AB35SX060100135

  • Peripheral angioplasty balloon catheter, drug-coated
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