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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® AV Drug Coated Balloon PTA Catheter 5x80x40
LUTONIX, INC.
LX3540580V
Not in Commercial Distribution

  • 00801741135118 ()

  • Catheter Length, 40 centimeter
  • Balloon Diameter, 5 millimeter
  • Balloon Length, 80 millimeter
LX3540580V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 5x60x40
LUTONIX, INC.
LX3540560V
Not in Commercial Distribution

  • 00801741135101 ()

  • Balloon Length, 60 millimeter
  • Balloon Diameter, 5 millimeter
  • Catheter Length, 40 centimeter
LX3540560V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 5x40x40
LUTONIX, INC.
LX3540540V
Not in Commercial Distribution

  • 00801741135095 ()

  • Balloon Length, 40 millimeter
  • Balloon Diameter, 5 millimeter
  • Catheter Length, 40 centimeter
LX3540540V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 4x100x40
LUTONIX, INC.
LX35404100V
Not in Commercial Distribution

  • 00801741135088 ()

  • Balloon Diameter, 4 millimeter
  • Catheter Length, 40 centimeter
  • Balloon Length, 100 millimeter
LX35404100V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 4x80x40
LUTONIX, INC.
LX3540480V
Not in Commercial Distribution

  • 00801741135071 ()

  • Cathether Length, 40 centimeter
  • Balloon Diameter, 4 millimeter
  • Balloon Length, 80 millimeter
LX3540480V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 4x60x40
LUTONIX, INC.
LX3540460V
Not in Commercial Distribution

  • 00801741135064 ()

  • Catheter Length, 40 centimeter
  • Balloon Diameter, 4 millimeter
  • Balloon Length, 60 millimeter
LX3540460V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 4x40x40
LUTONIX, INC.
LX3540440V
Not in Commercial Distribution

  • 00801741135057 ()

  • Balloon Diameter, 4 millimeter
  • Catheter Length, 40 centimeter
  • Balloon Length, 40 millimeter
LX3540440V

  • Peripheral angioplasty balloon catheter, drug-coated
EXTRACTION PLIERS STILLE narrow jaws 19 cm 7.5 in
Stille AB
105-16020-1
In Commercial Distribution

  • 07332339203832 ()

  • Length: 19 Centimeter
105-16020-1

  • Surgical flat-nosed pliers
EXTRACTION PLIERS STILLE 19 cm 7.5 in
Stille AB
105-16020
In Commercial Distribution

  • 07332339203825 ()

  • Length: 19 Centimeter
105-16020

  • Surgical flat-nosed pliers
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
6mm x 100mm x 80cm
Philips Image Guided Therapy Corporation
AB35SX060100080
In Commercial Distribution

  • 00810060550359 ()

  • Balloon Diameter: 6 Millimeter
  • Balloon Length: 100 Millimeter
  • Catheter Length: 80 Centimeter
AB35SX060100080

  • Peripheral angioplasty balloon catheter, drug-coated
6mm x 80mm x 135cm
Philips Image Guided Therapy Corporation
AB35SX060080135
In Commercial Distribution

  • 00810060550342 ()

  • Balloon Diameter: 6 Millimeter
  • Balloon Length: 80 Millimeter
  • Catheter Length: 135 Centimeter
AB35SX060080135

  • Peripheral angioplasty balloon catheter, drug-coated
6mm x 80mm x 80cm
Philips Image Guided Therapy Corporation
AB35SX060080080
In Commercial Distribution

  • 00810060550335 ()

  • Balloon Diameter: 6 Millimeter
  • Balloon Length: 80 Millimeter
  • Catheter Length: 80 Centimeter
AB35SX060080080

  • Peripheral angioplasty balloon catheter, drug-coated
6mm x 60mm x 135cm
Philips Image Guided Therapy Corporation
AB35SX060060135
In Commercial Distribution

  • 00810060550328 ()

  • Balloon Diameter: 6 Millimeter
  • Balloon Length: 60 Millimeter
  • Catheter Length: 135 Centimeter
AB35SX060060135

  • Peripheral angioplasty balloon catheter, drug-coated
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