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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 - 00801741135224

Lutonix® AV Drug Coated Balloon PTA Catheter 9x20x40
LUTONIX, INC.
LX3540920V
In Commercial Distribution

  • 00801741135224 ()

  • Balloon Length, 20 millimeter
  • Balloon Diameter, 9 millimeter
  • Catheter Length, 40 centimeter
LX3540920V

  • 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

M-50 - 04035479001575

No Description
BIOTRONIK SE & Co. KG
112149
In Commercial Distribution

  • 04035479001575 ()
112149

  • Cardiac pulse generator test magnet

ThinPrep 2000 Processor - 15420045507005

Processes liquid based cytologic specimens to produce a uniform layer of cells on a glass microsope slide.
Hologic, Inc.
ThinPrep 2000 Processor
In Commercial Distribution

  • 15420045507005 ()
PRD-04184

  • Microscope slide maker IVD

ThinPrep 2000 Processor - 15420045500839

Processes liquid based cytologic specimens to produce a uniform layer of cells on a glass microsope slide.
Hologic, Inc.
ThinPrep 2000 Processor
In Commercial Distribution

  • 15420045500839 ()
70031-001

  • Microscope slide maker IVD

Motiva® SmoothSilk® Round Breast Implant - 07445161002174

Motiva® SmoothSilk® Round Breast Implant Round Breast Implant - Full 625 cc
Establishment Labs S.A.
RSF-625+
In Commercial Distribution

  • 07445161002174 ()
RSF-625+

  • Silicone gel-filled breast implant, smooth-surface

Motiva® SmoothSilk® Round Breast Implant - 07445161002150

Motiva® SmoothSilk® Round Breast Implant Round Breast Implant - Full 500 cc
Establishment Labs S.A.
RSF-500+
In Commercial Distribution

  • 07445161002150 ()
RSF-500+

  • Silicone gel-filled breast implant, smooth-surface

Motiva® SmoothSilk® Round Breast Implant - 07445161002143

Motiva® SmoothSilk® Round Breast Implant Round Breast Implant - Full 450 cc
Establishment Labs S.A.
RSF-450+
In Commercial Distribution

  • 07445161002143 ()
RSF-450+

  • Silicone gel-filled breast implant, smooth-surface

Motiva® SmoothSilk® Round Breast Implant - 07445161002136

Motiva® SmoothSilk® Round Breast Implant Round Breast Implant - Full 425 cc
Establishment Labs S.A.
RSF-425+
In Commercial Distribution

  • 07445161002136 ()
RSF-425+

  • Silicone gel-filled breast implant, smooth-surface

Motiva® SmoothSilk® Round Breast Implant - 07445161002129

Motiva® SmoothSilk® Round Breast Implant Round Breast Implant - Full 400 cc
Establishment Labs S.A.
RSF-400+
In Commercial Distribution

  • 07445161002129 ()
RSF-400+

  • Silicone gel-filled breast implant, smooth-surface
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