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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® Drug Coated Balloon - 00801741176944

LUTONIX® 018 Drug Coated Balloon PTA Catheter 018 4X40MMX75CM
LUTONIX, INC.
LX18754404F
In Commercial Distribution

  • 00801741176944 ()

  • Balloon Diameter, 4 Millimeter
  • Catheter Length, 75 Centimeter
  • Balloon Length, 40 Millimeter
LX18754404F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741163470

Lutonix 035 DCB, 7mm x 220mm x 130cm, 5F
LUTONIX, INC.
LX3513072205F
In Commercial Distribution

  • 00801741163470 ()

  • Balloon Length, 220 Millimeter
  • Balloon Diameter, 7 Millimeter
  • Catheter Length, 130 Centimeter
LX3513072205F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741163463

Lutonix 035 DCB, 7mm x 150mm x 130cm, 5F
LUTONIX, INC.
LX3513071505F
In Commercial Distribution

  • 00801741163463 ()

  • Balloon Length, 150 Millimeter
  • Catheter Length, 130 Centimeter
  • Balloon Diameter, 7 Millimeter
LX3513071505F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741163456

Lutonix 035 DCB, 7mm x 120mm x 130cm, 5F
LUTONIX, INC.
LX3513071205F
In Commercial Distribution

  • 00801741163456 ()

  • Balloon Length, 120 Millimeter
  • Catheter Length, 130 Centimeter
  • Balloon Diameter, 7 Millimeter
LX3513071205F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741163449

Lutonix 035 DCB, 7mm x 100mm x 130cm, 5F
LUTONIX, INC.
LX3513071005F
In Commercial Distribution

  • 00801741163449 ()

  • Catheter Length, 130 Centimeter
  • Balloon Diameter, 7 Millimeter
  • Balloon Length, 100 Millimeter
LX3513071005F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741163432

Lutonix 035 DCB, 7mm x 80mm x 130cm, 5F
LUTONIX, INC.
LX351307805F
In Commercial Distribution

  • 00801741163432 ()

  • Catheter Length, 130 Centimeter
  • Balloon Length, 80 Millimeter
  • Balloon Diameter, 7 Millimeter
LX351307805F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741163425

Lutonix 035 DCB, 6mm x 220mm x 130cm, 5F
LUTONIX, INC.
LX3513062205F
In Commercial Distribution

  • 00801741163425 ()

  • Balloon Diameter, 6 Millimeter
  • Catheter Length, 130 Centimeter
  • Balloon Length, 220 Millimeter
LX3513062205F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741163418

Lutonix 035 DCB, 5mm x 220mm x 130cm, 5F
LUTONIX, INC.
LX3513052205F
In Commercial Distribution

  • 00801741163418 ()

  • Balloon Length, 220 Millimeter
  • Balloon Diameter, 5 Millimeter
  • Catheter Length, 130 Centimeter
LX3513052205F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741163401

Lutonix 035 DCB, 4mm x 220mm x 130cm, 5F
LUTONIX, INC.
LX3513042205F
In Commercial Distribution

  • 00801741163401 ()

  • Balloon Length, 220 Millimeter
  • Balloon Diameter, 4 Millimeter
  • Catheter Length, 130 Centimeter
LX3513042205F

  • Peripheral angioplasty balloon catheter, drug-coated

N/A - 20721902034132

PLIERS 836-062 REDUCTION PLIERS LOCKSCRW
MEDTRONIC SOFAMOR DANEK, INC.
836-062
In Commercial Distribution

  • 20721902034132 ()
  • 00721902034138 ()


  • Surgical flat-nosed pliers

Adler Instrument Company - 00810123208791

Pliers, Slip Joint, BW 10mm OL 195mm (7-5/8")
Adler, Inc.
37-5555
In Commercial Distribution

  • 00810123208791 ()


  • Surgical flat-nosed pliers

Adler Instrument Company - 00810123204861

FLAT NOSE PLIERS 6-1/2 W/SIDE
Adler, Inc.
37-5580
In Commercial Distribution

  • 00810123204861 ()


  • Surgical flat-nosed pliers

Disposable Biopsy Valve - 06970401817146

Non-sterile
Zhejiang Chuangxiang Medical Technology Co., LTD.
MD-B-BV02
In Commercial Distribution

  • 16970401817150 ()
  • 06970401817146 ()
  • 26970401817164 ()


  • Endoscope working-channel valve, single-use

Disposable Biopsy Valve - 06970401817139

No Description
Zhejiang Chuangxiang Medical Technology Co., LTD.
MD-A-BV02
In Commercial Distribution

  • 16970401817174 ()
  • 06970401817139 ()
  • 26970401817188 ()


  • Endoscope working-channel valve, single-use

Disposable Biopsy Valve - 06970401814343

product color: purple
Zhejiang Chuangxiang Medical Technology Co., LTD.
MD-A-BV01
In Commercial Distribution

  • 26970401814361 ()
  • 16970401814357 ()
  • 06970401814343 ()


  • Endoscope working-channel valve, single-use

Disposable Biopsy Valve - 06970900850934

No Description
Yangzhou Fartley Medical Instrument Technology Co., Ltd
FTL-BV-O-EO
In Commercial Distribution

  • 06970900850934 ()


  • Endoscope working-channel valve, single-use

Andorate® - 06970661241545

No Description
Smartdata Suzhou Co., Ltd.
GAR028S
In Commercial Distribution

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


  • Endoscope working-channel valve, single-use

LUTONIX® Drug Coated Balloon - 00801741088773

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® Drug Coated Balloon - 00801741088766

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® Drug Coated Balloon - 00801741088759

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® Drug Coated Balloon - 00801741088742

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® Drug Coated Balloon - 00801741088735

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® Drug Coated Balloon - 00801741088728

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® Drug Coated Balloon - 00801741088711

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® Drug Coated Balloon - 00801741088704

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® Drug Coated Balloon - 00801741088698

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® Drug Coated Balloon - 00801741088681

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® Drug Coated Balloon - 00801741088674

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® Drug Coated Balloon - 00801741088667

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® Drug Coated Balloon - 00801741088650

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® Drug Coated Balloon - 00801741088643

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® Drug Coated Balloon - 00801741088636

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® Drug Coated Balloon - 00801741088629

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® Drug Coated Balloon - 00801741088612

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® Drug Coated Balloon - 00801741088605

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® Drug Coated Balloon - 00801741088599

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® Drug Coated Balloon - 00801741088582

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035 130cm 4x60mm
LUTONIX, INC.
LX35130460
Not in Commercial Distribution

  • 00801741088582 ()

  • Balloon Diameter,4 Millimeter
  • Catheter Length,130 Centimeter
  • Balloon Length,60 Millimeter
LX35130460

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741088575

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® Drug Coated Balloon - 00801741088568

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035 130cm 6x40mm
LUTONIX, INC.
LX35130640
Not in Commercial Distribution

  • 00801741088568 ()

  • Catheter Length,130 Centimeter
  • Balloon Length,40 Millimeter
  • Balloon Diameter,6 Millimeter
LX35130640

  • Peripheral angioplasty balloon catheter, drug-coated

Lutonix® Drug Coated Balloon - 00801741088551

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035 130cm 5x40mm
LUTONIX, INC.
LX35130540
Not in Commercial Distribution

  • 00801741088551 ()

  • Catheter Length,130 Centimeter
  • Balloon Length,40 Millimeter
  • Balloon Diameter,5 Millimeter
LX35130540

  • Peripheral angioplasty balloon catheter, drug-coated
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