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 018 4X100MMX150CM
LUTONIX, INC.
LX1815041004F
In Commercial Distribution

  • 00801741199226 ()

  • Balloon Diameter, 4 millimeter
  • Balloon Length, 100 millimeter
  • Catheter Length, 150 centimeter
LX1815041004F

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix 018 4X80MMX150CM
LUTONIX, INC.
LX181504804F
In Commercial Distribution

  • 00801741199219 ()

  • Catheter Length, 150 centimeter
  • Balloon Length, 80 millimeter
  • Balloon Diameter, 4 millimeter
LX181504804F

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix 018 4X60MMX150CM
LUTONIX, INC.
LX181504604F
In Commercial Distribution

  • 00801741199202 ()

  • Balloon Diameter, 4 millimeter
  • Catheter Length, 150 centimeter
  • Balloon Length, 60 millimeter
LX181504604F

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix 018 4X40MMX150CM
LUTONIX, INC.
LX181504404F
In Commercial Distribution

  • 00801741199196 ()

  • Catheter Length, 150 centimeter
  • Balloon Diameter, 4 millimeter
  • Balloon Length, 40 millimeter
LX181504404F

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 6x40x100
LUTONIX, INC.
LX35100640V
Not in Commercial Distribution

  • 00801741135637 ()

  • Balloon Diameter, 6 millimeter
  • Balloon Length, 40 millimeter
  • Catheter Length, 100 centimeter
LX35100640V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 5x100x100
LUTONIX, INC.
LX351005100V
Not in Commercial Distribution

  • 00801741135620 ()

  • Catheter Length, 100 centimeter
  • Balloon Diameter, 5 millimeter
  • Balloon Length,100 millimeter
LX351005100V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 4x80x100
LUTONIX, INC.
LX35100480V
Not in Commercial Distribution

  • 00801741135576 ()

  • Balloon Length, 80 millimeter
  • Balloon Diameter, 4 millimeter
  • Catheter Length, 100 centimeter
LX35100480V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 4x40x100
LUTONIX, INC.
LX35100440V
Not in Commercial Distribution

  • 00801741135552 ()

  • Balloon Diameter, 4 millimeter
  • Balloon Length, 40 millimeter
  • Catheter Length, 100 centimeter
LX35100440V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 12x20x75
LUTONIX, INC.
LX35751220V
In Commercial Distribution

  • 00801741135538 ()

  • Catheter Length, 75 centimeter
  • Balloon Diameter, 12 millimeter
  • Balloon Length, 20 millimeter
LX35751220V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 10x40x75
LUTONIX, INC.
LX35751040V
In Commercial Distribution

  • 00801741135514 ()

  • Balloon Diameter, 10 millimeter
  • Balloon Length, 40 millimeter
  • Catheter Length, 75 centimeter
LX35751040V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 9x60x75
LUTONIX, INC.
LX3575960V
In Commercial Distribution

  • 00801741135491 ()

  • Balloon Length, 60 millimeter
  • Catheter Length, 75 centimeter
  • Balloon Diameter, 9 millimeter
LX3575960V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 8x60x75
LUTONIX, INC.
LX3575860V
In Commercial Distribution

  • 00801741135460 ()

  • Balloon Length, 60 millimeter
  • Balloon Diameter, 8 millimeter
  • Catheter Length, 75 centimeter
LX3575860V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 7x60x75
LUTONIX, INC.
LX3575760V
In Commercial Distribution

  • 00801741135439 ()

  • Catheter Length, 75 centimeter
  • Balloon Diameter, 7 millimeter
  • Balloon Length, 60millimeter
LX3575760V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 6x100x75
LUTONIX, INC.
LX35756100V
In Commercial Distribution

  • 00801741135415 ()

  • Balloon Length, 100 millimeter
  • Catheter Length, 75 centimeter
  • Balloon Diameter, 6 millimeter
LX35756100V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 6x60x75
LUTONIX, INC.
LX3575660V
In Commercial Distribution

  • 00801741135392 ()

  • Balloon Length, 60 millimeter
  • Catheter Length, 75 centimeter
  • Balloon Diameter,6 millimeter
LX3575660V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 5x100x75
LUTONIX, INC.
LX35755100V
In Commercial Distribution

  • 00801741135378 ()

  • Balloon Length, 100 millimeter
  • Balloon Diameter, 5 millimeter
  • Catheter Length,75 centimeter
LX35755100V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 5x80x75
LUTONIX, INC.
LX3575580V
In Commercial Distribution

  • 00801741135361 ()

  • Balloon Diameter,5 millimeter
  • Balloon Length, 80 millimeter
  • Catheter Length, 75 centimeter
LX3575580V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 5x40x75
LUTONIX, INC.
LX3575540V
In Commercial Distribution

  • 00801741135347 ()

  • Balloon Length, 40 millimeter
  • Catheter Length, 75 centimeter
  • Balloon Diameter, 5 millimeter
LX3575540V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 4x80x75
LUTONIX, INC.
LX3575480V
In Commercial Distribution

  • 00801741135323 ()

  • Catheter Length, 75 centimeter
  • Balloon Diameter, 4 millimeter
  • Balloon Length, 80 millimeter
LX3575480V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 12x20x40
LUTONIX, INC.
LX35401220V
In Commercial Distribution

  • 00801741135286 ()

  • Balloon Length, 20 millimeter
  • Balloon Diameter, 12 millimeter
  • Catheter Length, 40 centimeter
LX35401220V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 9x60x40
LUTONIX, INC.
LX3540960V
Not in Commercial Distribution

  • 00801741135248 ()

  • Catheter Length, 40 centimeter
  • Balloon Length, 60 millimeter
  • Balloon Diameter, 9 millimeter
LX3540960V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 9x40x40
LUTONIX, INC.
LX3540940V
Not in Commercial Distribution

  • 00801741135231 ()

  • Balloon Diameter, 9 millimeter
  • Balloon Length, 40 millimeter
  • Catheter Length, 40 centimeter
LX3540940V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 8x60x40
LUTONIX, INC.
LX3540860V
In Commercial Distribution

  • 00801741135217 ()

  • Catheter Length, 40 centimeter
  • Balloon Diameter, 8 millimeter
  • Balloon Length, 60 millimeter
LX3540860V

  • Peripheral angioplasty balloon catheter, drug-coated
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® 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® 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® 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® 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 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 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
PLIERS 836-062 REDUCTION PLIERS LOCKSCRW
MEDTRONIC SOFAMOR DANEK, INC.
836-062
In Commercial Distribution

  • 20721902034132 ()
  • 00721902034138 ()


  • Surgical flat-nosed pliers
No Description
Yangzhou Fartley Medical Instrument Technology Co., Ltd
FTL-BV-O-EO
In Commercial Distribution

  • 06970900850934 ()


  • Endoscope working-channel valve, single-use
No Description
Smartdata Suzhou Co., Ltd.
GAR028S
In Commercial Distribution

  • 16970661241542 ()
  • 06970661241545 ()
  • 26970661241549 ()


  • Endoscope working-channel valve, single-use
LUTONIX® 035 Drug Coated Balloon PTA Catheter, 130cm, 7x150mm
LUTONIX, INC.
LX351307150
Not in Commercial Distribution

  • 00801741088773 ()

  • Balloon Diameter, 7 Millimeter
  • Catheter Length, 130 Centimeter
  • Balloon Length, 150 Millimeter
LX351307150

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 6x150mm
LUTONIX, INC.
LX351306150
Not in Commercial Distribution

  • 00801741088766 ()

  • Balloon Diameter
  • Balloon Length
  • Catheter Length
LX351306150

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 5x150mm
LUTONIX, INC.
LX351305150
Not in Commercial Distribution

  • 00801741088759 ()

  • Balloon Diameter
  • Catheter Length
  • Balloon Length
LX351305150

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 4x150mm
LUTONIX, INC.
LX351304150
Not in Commercial Distribution

  • 00801741088742 ()

  • Catheter Length
  • Balloon Diameter
  • Balloon Length
LX351304150

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 035 Drug Coated Balloon PTA Catheter, 130cm, 7x120mm
LUTONIX, INC.
LX351307120
In Commercial Distribution

  • 00801741088735 ()

  • Catheter Length, 130 Centimeter
  • Balloon Diameter, 7 Millimeter
  • Balloon Length, 120 Millimeter
LX351307120

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 6x120mm
LUTONIX, INC.
LX351306120
Not in Commercial Distribution

  • 00801741088728 ()

  • Catheter Length
  • Balloon Diameter
  • Balloon Length
LX351306120

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 5x120mm
LUTONIX, INC.
LX351305120
Not in Commercial Distribution

  • 00801741088711 ()

  • Balloon Diameter
  • Catheter Length
  • Balloon Length
LX351305120

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 4x120mm
LUTONIX, INC.
LX351304120
Not in Commercial Distribution

  • 00801741088704 ()

  • Balloon Length
  • Catheter Length
  • Balloon Diameter
LX351304120

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 035 Drug Coated Balloon PTA Catheter, 130cm 7x100mm
LUTONIX, INC.
LX351307100
Not in Commercial Distribution

  • 00801741088698 ()

  • Balloon Diameter, 7 Millimeter
  • Balloon Length, 100 Millimeter
  • Catheter Length, 130 Centimeter
LX351307100

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 035 Drug Coated Balloon PTA Catheter .035 130cm 6x100mm
LUTONIX, INC.
LX351306100
Not in Commercial Distribution

  • 00801741088681 ()

  • Balloon Length,100 Millimeter
  • Catheter Length,130 Centimeter
  • Balloon Diameter,6 Millimeter
LX351306100

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 035 Drug Coated Balloon PTA Catheter .035 130cm 5x100mm
LUTONIX, INC.
LX351305100
Not in Commercial Distribution

  • 00801741088674 ()

  • Balloon Diameter,5 Millimeter
  • Catheter Length,130 Centimeter
  • Balloon Length,100 Millimeter
LX351305100

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 035 Drug Coated Balloon PTA Catheter .035 130cm 4x100mm
LUTONIX, INC.
LX351304100
Not in Commercial Distribution

  • 00801741088667 ()

  • Balloon Diameter,4 Millimeter
  • Balloon Length,100 Millimeter
  • Catheter Length,130 Centimeter
LX351304100

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 035 Drug Coated Balloon PTA Catheter, 130cm, 7x80mm
LUTONIX, INC.
LX35130780
In Commercial Distribution

  • 00801741088650 ()

  • Balloon Length, 80 Millimeter
  • Balloon Diameter, 7 Millimeter
  • Catheter Length, 130 Centimeter
LX35130780

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 035 Drug Coated Balloon PTA Catheter .035 130cm 6x80mm
LUTONIX, INC.
LX35130680
Not in Commercial Distribution

  • 00801741088643 ()

  • Balloon Length,80 Millimeter
  • Catheter Length,130 Centimeter
  • Balloon Diameter,6 Millimeter
LX35130680

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 035 Drug Coated Balloon PTA Catheter .035 130cm 5x80mm
LUTONIX, INC.
LX35130580
Not in Commercial Distribution

  • 00801741088636 ()

  • Balloon Diameter,5 Millimeter
  • Balloon Length,80 Millimeter
  • Catheter Length,130 Centimeter
LX35130580

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 035 Drug Coated Balloon PTA Catheter .035 130cm 4x80mm
LUTONIX, INC.
LX35130480
Not in Commercial Distribution

  • 00801741088629 ()

  • Balloon Length,80 Millimeter
  • Balloon Diameter,4 Millimeter
  • Catheter Length,130 Centimeter
LX35130480

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 7x60mm
LUTONIX, INC.
LX35130760
Not in Commercial Distribution

  • 00801741088612 ()

  • Catheter Length, 130 Centimeter
  • Balloon Length, 60 Millimeter
  • Balloon Diameter, 7 Millimeter
LX35130760

  • Peripheral angioplasty balloon catheter, drug-coated
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