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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 - 00801741135200

Lutonix® AV Drug Coated Balloon PTA Catheter 8x40x40
LUTONIX, INC.
LX3540840V
In Commercial Distribution

  • 00801741135200 ()

  • Catheter Length, 40 centimeter
  • Balloon Diameter, 8 millimeter
  • Balloon Length, 40 millimeter
LX3540840V

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX ® 035 Drug Coated Balloon PTA Catheter - 00801741135194

Lutonix® AV Drug Coated Balloon PTA Catheter 8x20x40
LUTONIX, INC.
LX3540820V
In Commercial Distribution

  • 00801741135194 ()

  • Balloon Length, 20 millimeter
  • Catheter Length, 40 centimeter
  • Balloon Diameter, 8 millimeter
LX3540820V

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX ® 035 Drug Coated Balloon PTA Catheter - 00801741135187

Lutonix® AV Drug Coated Balloon PTA Catheter 7x60x40
LUTONIX, INC.
LX3540760V
In Commercial Distribution

  • 00801741135187 ()

  • Balloon Length, 60 millimeter
  • Balloon Diameter, 7 millimeter
  • Catheter Length, 40 centimeter
LX3540760V

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX ® 035 Drug Coated Balloon PTA Catheter - 00801741135170

Lutonix® AV Drug Coated Balloon PTA Catheter 7x40x40
LUTONIX, INC.
LX3540740V
In Commercial Distribution

  • 00801741135170 ()

  • Balloon Length, 40 millimeter
  • Balloon Diameter, 7 millimeter
  • Catheter Length, 40 centimeter
LX3540740V

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX ® 035 Drug Coated Balloon PTA Catheter - 00801741135163

Lutonix® AV Drug Coated Balloon PTA Catheter 6x100x40
LUTONIX, INC.
LX35406100V
Not in Commercial Distribution

  • 00801741135163 ()

  • Balloon Length, 100 millimeter
  • Balloon Diameter, 6 millimeter
  • Catheter Length, 40 centimeter
LX35406100V

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX ® 035 Drug Coated Balloon PTA Catheter - 00801741135156

Lutonix® AV Drug Coated Balloon PTA Catheter 6x80x40
LUTONIX, INC.
LX3540680V
Not in Commercial Distribution

  • 00801741135156 ()

  • Catheter Length, 40 centimeter
  • Balloon Length, 80 millimeter
  • Balloon Diameter, 6 millimeter
LX3540680V

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX ® 035 Drug Coated Balloon PTA Catheter - 00801741135149

Lutonix® AV Drug Coated Balloon PTA Catheter 6x60x40
LUTONIX, INC.
LX3540660V
Not in Commercial Distribution

  • 00801741135149 ()

  • Balloon Length, 60 millimeter
  • Catheter Length, 40 centimeter
  • Balloon Diameter, 6 millimeter
LX3540660V

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX ® 035 Drug Coated Balloon PTA Catheter - 00801741135132

Lutonix® AV Drug Coated Balloon PTA Catheter 6x40x40
LUTONIX, INC.
LX3540640V
Not in Commercial Distribution

  • 00801741135132 ()

  • Catheter Length, 40 centimeter
  • Balloon Diameter, 6 millimeter
  • Balloon Length, 40 millimeter
LX3540640V

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX ® 035 Drug Coated Balloon PTA Catheter - 00801741135125

Lutonix® AV Drug Coated Balloon PTA Catheter 5x100x40
LUTONIX, INC.
LX35405100V
Not in Commercial Distribution

  • 00801741135125 ()

  • Catheter Length, 40 centimeter
  • Balloon Diameter, 5 millimeter
  • Balloon Length, 100 millimeter
LX35405100V

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX ® 035 Drug Coated Balloon PTA Catheter - 00801741135118

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 ® 035 Drug Coated Balloon PTA Catheter - 00801741135101

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 ® 035 Drug Coated Balloon PTA Catheter - 00801741135095

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 ® 035 Drug Coated Balloon PTA Catheter - 00801741135088

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 ® 035 Drug Coated Balloon PTA Catheter - 00801741135071

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® 035 Drug Coated Balloon PTA Catheter - 00801741135064

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 ® 035 Drug Coated Balloon PTA Catheter - 00801741135057

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

STILLE Pliers - 07332339203832

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

STILLE Pliers - 07332339203825

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

Stellarex 0.035" OTW drug-coated angioplasty balloon - 00810060550427

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

Stellarex 0.035" OTW drug-coated angioplasty balloon - 00810060550410

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

Stellarex 0.035" OTW drug-coated angioplasty balloon - 00810060550403

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

Stellarex 0.035" OTW drug-coated angioplasty balloon - 00810060550397

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

Stellarex 0.035" OTW drug-coated angioplasty balloon - 00810060550380

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

Stellarex 0.035" OTW drug-coated angioplasty balloon - 00810060550373

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

Stellarex 0.035" OTW drug-coated angioplasty balloon - 00810060550366

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

Stellarex 0.035" OTW drug-coated angioplasty balloon - 00810060550359

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

Stellarex 0.035" OTW drug-coated angioplasty balloon - 00810060550342

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

Stellarex 0.035" OTW drug-coated angioplasty balloon - 00810060550335

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

Stellarex 0.035" OTW drug-coated angioplasty balloon - 00810060550328

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

Stellarex 0.035" OTW drug-coated angioplasty balloon - 00810060550311

6mm x 60mm x 80cm
Philips Image Guided Therapy Corporation
AB35SX060060080
In Commercial Distribution

  • 00810060550311 ()

  • Balloon Diameter: 6 Millimeter
  • Balloon Length: 60 Millimeter
  • Catheter Length: 80 Centimeter
AB35SX060060080

  • Peripheral angioplasty balloon catheter, drug-coated
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