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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DCB IAV07004008P 07.00 L040 UL0800 US
MEDTRONIC, INC.
IAV07004008P
In Commercial Distribution

  • 00763000232610 ()

  • Outer Diameter: 7.0 Millimeter
  • Length: 40.0 Millimeter


  • Peripheral angioplasty balloon catheter, drug-coated
DCB IAV06008008P 06.00 L080 UL0800 US
MEDTRONIC, INC.
IAV06008008P
In Commercial Distribution

  • 00763000232580 ()

  • Outer Diameter: 6.0 Millimeter
  • Length: 80.0 Millimeter


  • Peripheral angioplasty balloon catheter, drug-coated
DCB IAV06006008P 06.00 L060 UL0800 US
MEDTRONIC, INC.
IAV06006008P
In Commercial Distribution

  • 00763000232573 ()

  • Length: 60.0 Millimeter
  • Outer Diameter: 6.0 Millimeter


  • Peripheral angioplasty balloon catheter, drug-coated
DCB IAV05012008P 05.00 L120 UL0800 US
MEDTRONIC, INC.
IAV05012008P
In Commercial Distribution

  • 00763000232542 ()

  • Outer Diameter: 5.0 Millimeter
  • Length: 120.0 Millimeter


  • Peripheral angioplasty balloon catheter, drug-coated
DCB IAV05006008P 05.00 L060 UL0800 US
MEDTRONIC, INC.
IAV05006008P
In Commercial Distribution

  • 00763000232528 ()

  • Length: 60.0 Millimeter
  • Outer Diameter: 5.0 Millimeter


  • Peripheral angioplasty balloon catheter, drug-coated
DCB IAV04012008P 04.00 L120 UL0800 US
MEDTRONIC, INC.
IAV04012008P
In Commercial Distribution

  • 00763000232498 ()

  • Length: 120.0 Millimeter
  • Outer Diameter: 4.0 Millimeter


  • Peripheral angioplasty balloon catheter, drug-coated
GRIPPER EX0918024 ROD LONG HANDLE
MEDTRONIC SOFAMOR DANEK, INC.
EX0918024
In Commercial Distribution

  • 00763000216757 ()


  • Surgical flat-nosed pliers
GRIPPER 5597060 6.0/6.35 ROD
MEDTRONIC SOFAMOR DANEK, INC.
5597060
In Commercial Distribution

  • 00763000583507 ()


  • Surgical flat-nosed pliers
GRIPPER 5597055 5.5 ROD
MEDTRONIC SOFAMOR DANEK, INC.
5597055
In Commercial Distribution

  • 00763000583491 ()


  • Surgical flat-nosed pliers
GRIPPER 5597050 4.75/5.0 ROD
MEDTRONIC SOFAMOR DANEK, INC.
5597050
In Commercial Distribution

  • 00763000583484 ()


  • Surgical flat-nosed pliers
Endoscopic Seal, Type I (adapter)
Well Lead Medical Co.,Ltd
U04D020110
In Commercial Distribution

  • 16944932785127 ()
  • 06944932785120 ()
  • 26944932785124 ()


  • Endoscope working-channel valve, single-use
Endoscopic Seal, Type I
Well Lead Medical Co.,Ltd
U04D010110
In Commercial Distribution

  • 16944932785110 ()
  • 06944932785113 ()
  • 26944932785117 ()


  • Endoscope working-channel valve, single-use
HOLDER X0324058 4.5MM
MEDTRONIC SOFAMOR DANEK, INC.
X0324058
In Commercial Distribution

  • 00763000953058 ()


  • Surgical flat-nosed pliers
GRIPPER X0324050 POWER WITH RELEASE
MEDTRONIC SOFAMOR DANEK, INC.
X0324050
In Commercial Distribution

  • 00763000951375 ()


  • Surgical flat-nosed pliers
LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 6x80mm
LUTONIX, INC.
BSCLX3575680
In Commercial Distribution

  • 00801741098574 ()

  • Balloon Length, 80mm
  • Catheter Length, 75cm
  • Balloon Diameter, 6mm
BSCLX3575680

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 5x60mm
LUTONIX, INC.
BSCLX3575560
In Commercial Distribution

  • 00801741098536 ()

  • Balloon Length, 60mm
  • Balloon Diameter, 5mm
  • Catheter Length, 75cm
BSCLX3575560

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 5x100mm
LUTONIX, INC.
BSCLX35755100
In Commercial Distribution

  • 00801741098529 ()

  • Balloon Diameter, 5mm
  • Catheter Length, 75cm
  • Balloon Length, 100mm
BSCLX35755100

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 6x80mm
LUTONIX, INC.
BSCLX35130680
Not in Commercial Distribution

  • 00801741098505 ()

  • Balloon Length, 80mm
  • Catheter Length, 130cm
  • Balloon Diameter,6mm
BSCLX35130680

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 6x60mm
LUTONIX, INC.
BSCLX35130660
Not in Commercial Distribution

  • 00801741098499 ()

  • Balloon Length, 60mm
  • Catheter Length, 130cm
  • Balloon Diameter, 6mm
BSCLX35130660

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 6x40mm
LUTONIX, INC.
BSCLX35130640
Not in Commercial Distribution

  • 00801741098482 ()

  • Catheter Length, 130 Centimeter
  • Balloon Length, 40 Millimeter
  • Balloon Diameter, 6 Millimeter
BSCLX35130640

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 6x100mm
LUTONIX, INC.
BSCLX351306100
Not in Commercial Distribution

  • 00801741098475 ()

  • Balloon Diameter, 6 Millimeter
  • Catheter Length, 130 Centimeter
  • Balloon Length, 100 Millimeter
BSCLX351306100

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 5x80mm
LUTONIX, INC.
BSCLX35130580
Not in Commercial Distribution

  • 00801741098468 ()

  • Catheter Length, 130 Centimeter
  • Balloon Length, 80 Millimeter
  • Balloon Diameter, 5 Millimeter
BSCLX35130580

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 5x60mm
LUTONIX, INC.
BSCLX35130560
Not in Commercial Distribution

  • 00801741098451 ()

  • Catheter Length, 130 Centimeter
  • Balloon Length, 60 Millimeter
  • Balloon Diameter, 5 Millimeter
BSCLX35130560

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 5x40mm
LUTONIX, INC.
BSCLX35130540
Not in Commercial Distribution

  • 00801741098444 ()

  • Balloon Length, 40 Millimeter
  • Balloon Diameter, 5 Millimeter
  • Catheter Length, 130 Centimeter
BSCLX35130540

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 5x100mm
LUTONIX, INC.
BSCLX351305100
Not in Commercial Distribution

  • 00801741098437 ()

  • Balloon Length, 100 Millimeter
  • Catheter Length, 130 Centimeter
  • Balloon Diameter, 5 Millimeter
BSCLX351305100

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 4x80mm
LUTONIX, INC.
BSCLX35130480
Not in Commercial Distribution

  • 00801741098420 ()

  • Balloon Length, 80 Millimeter
  • Balloon Diameter, 4 Millimeter
  • Catheter Length, 130 Centimeter
BSCLX35130480

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 4x60mm
LUTONIX, INC.
BSCLX35130460
Not in Commercial Distribution

  • 00801741098413 ()

  • Catheter Length, 130 Centimeter
  • Balloon Length, 60 Millimeter
  • Balloon Diameter, 4 Millimeter
BSCLX35130460

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 035 Drug Coated Balloon PTA Catheter .035 130cm 4x40mm
LUTONIX, INC.
BSCLX35130440
Not in Commercial Distribution

  • 00801741098406 ()

  • Catheter Length, 130 Centimeter
  • Balloon Diameter, 4 Millimeter
  • Balloon Length, 40 Millimeter
BSCLX35130440

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 035 Drug Coated Balloon PTA Catheter .035 130cm 4x100mm
LUTONIX, INC.
BSCLX351304100
Not in Commercial Distribution

  • 00801741098390 ()

  • Balloon Diameter, 4 Millimeter
  • Catheter Length, 130 Centimeter
  • Balloon Length, 100 Millimeter
BSCLX351304100

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 4x60mm
LUTONIX, INC.
BSCLX3575460
In Commercial Distribution

  • 00801741098383 ()

  • Balloon Length, 60 Millimeter
  • Balloon Diameter, 4 Millimeter
  • Catheter Length, 75 Centimeter
BSCLX3575460

  • 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 .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, 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 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
LUTONIX® 035 Drug Coated Balloon PTA Catheter .035 130cm 6x60mm
LUTONIX, INC.
LX35130660
Not in Commercial Distribution

  • 00801741088605 ()

  • Balloon Diameter,6 Millimeter
  • Balloon Length,60 Millimeter
  • Catheter Length,130 Centimeter
LX35130660

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 035 Drug Coated Balloon PTA Catheter .035 130cm 5x60mm
LUTONIX, INC.
LX35130560
Not in Commercial Distribution

  • 00801741088599 ()

  • Catheter Length,130 Centimeter
  • Balloon Diameter,5 Millimeter
  • Balloon Length,60 Millimeter
LX35130560

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 7x40mm
LUTONIX, INC.
LX35130740
Not in Commercial Distribution

  • 00801741088575 ()

  • Balloon Diameter, 7 Millimeter
  • Balloon Length, 40 Millimeter
  • Catheter Length, 130 Centimeter
LX35130740

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 035 Drug Coated Balloon PTA Catheter .035 130cm 4x40mm
LUTONIX, INC.
LX35130440
Not in Commercial Distribution

  • 00801741088544 ()

  • Catheter Length,130 Centimeter
  • Balloon Diameter,4 Millimeter
  • Balloon Length,40 Millimeter
LX35130440

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 100cm 5x150mm
LUTONIX, INC.
LX351005150
In Commercial Distribution

  • 00801741088476 ()

  • Balloon Diameter
  • Balloon Length
  • Catheter Length
LX351005150

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 100cm 6x120mm
LUTONIX, INC.
LX351006120
In Commercial Distribution

  • 00801741088445 ()

  • Balloon Diameter
  • Catheter Length
  • Balloon Length
LX351006120

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 100cm 5x120mm
LUTONIX, INC.
LX351005120
In Commercial Distribution

  • 00801741088438 ()

  • Balloon Length
  • Catheter Length
  • Balloon Diameter
LX351005120

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 100cm 4x120mm
LUTONIX, INC.
LX351004120
In Commercial Distribution

  • 00801741088421 ()

  • Catheter Length
  • Balloon Length
  • Balloon Diameter
LX351004120

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 035 Drug Coated Balloon PTA Catheter .035 100cm 5x100mm
LUTONIX, INC.
LX351005100
In Commercial Distribution

  • 00801741088391 ()

  • Balloon Diameter,5 Millimeter
  • Catheter Length,100 Centimeter
  • Balloon Length,100 Millimeter
LX351005100

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 035 Drug Coated Balloon PTA Catheter .035 100cm 6x80mm
LUTONIX, INC.
LX35100680
In Commercial Distribution

  • 00801741088360 ()

  • Balloon Diameter,6 Millimeter
  • Catheter Length,100 Centimeter
  • Balloon Length,80 Millimeter
LX35100680

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 035 Drug Coated Balloon PTA Catheter .035 100cm 4x80mm
LUTONIX, INC.
LX35100480
In Commercial Distribution

  • 00801741088346 ()

  • Balloon Diameter,4 Millimeter
  • Balloon Length,80 Millimeter
  • Catheter Length,100 Centimeter
LX35100480

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 035 Drug Coated Balloon PTA Catheter .035 100cm 6x60mm
LUTONIX, INC.
LX35100660
In Commercial Distribution

  • 00801741088322 ()

  • Balloon Diameter,6 Millimeter
  • Balloon Length,60 Millimeter
  • Catheter Length,100 Centimeter
LX35100660

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 035 Drug Coated Balloon PTA Catheter .035 100cm 4x60mm
LUTONIX, INC.
LX35100460
In Commercial Distribution

  • 00801741088308 ()

  • Balloon Diameter,4 Millimeter
  • Balloon Length,60 Millimeter
  • Catheter Length,100 Centimeter
LX35100460

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 035 Drug Coated Balloon PTA Catheter .035 100cm 6x40mm
LUTONIX, INC.
LX35100640
In Commercial Distribution

  • 00801741088285 ()

  • Balloon Length,40 Millimeter
  • Balloon Diameter,6 Millimeter
  • Catheter Length,100 Centimeter
LX35100640

  • Peripheral angioplasty balloon catheter, drug-coated
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