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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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Balloon Dilatation Catheter
OrbusNeich Medical (ShenZhen) Co., Ltd.
210-103-5UU
In Commercial Distribution

  • 06934955942037 ()

  • Outer Diameter: 1.0 Millimeter
  • Length: 10 Millimeter


  • Peripheral angioplasty balloon catheter, basic
  • Coronary angioplasty balloon catheter, basic
Balloon Dilatation Catheter
OrbusNeich Medical (ShenZhen) Co., Ltd.
210-083-5UU
In Commercial Distribution

  • 06934955942020 ()

  • Length: 8 Millimeter
  • Outer Diameter: 1.0 Millimeter


  • Peripheral angioplasty balloon catheter, basic
  • Coronary angioplasty balloon catheter, basic
Balloon Dilatation Catheter
OrbusNeich Medical (ShenZhen) Co., Ltd.
210-053-5UU
In Commercial Distribution

  • 06934955942013 ()

  • Outer Diameter: 1.0 Millimeter
  • Length: 5 Millimeter


  • Peripheral angioplasty balloon catheter, basic
  • Coronary angioplasty balloon catheter, basic
FLASH Ostial System, Dual Balloon Angioplasty Catheter, 5.0mm x 17mm
Verge Medical, Inc.
OCB5019BA
In Commercial Distribution

  • M917OCB5019BA0 ()

  • Catheter Length: 135cm
  • Distal Balloon Length: 17mm
  • Distal Balloon Diameter: 5.0mm
OCB5019BA

  • Peripheral angioplasty balloon catheter, basic
  • Coronary angioplasty balloon catheter, basic
FLASH Ostial System, Dual Balloon Angioplasty Catheter, 5.0mm x 12mm
Verge Medical, Inc.
OCB5014BA
In Commercial Distribution

  • M917OCB5014BA0 ()

  • Distal Balloon Diameter: 5.0mm
  • Distal Balloon Length: 12mm
  • Catheter Length: 135cm
OCB5014BA

  • Coronary angioplasty balloon catheter, basic
  • Peripheral angioplasty balloon catheter, basic
FLASH Ostial System, Dual Balloon Angioplasty Catheter, 4.5mm x 12mm
Verge Medical, Inc.
OCB4514BA
In Commercial Distribution

  • M917OCB4514BA0 ()

  • Distal Balloon Diameter: 4.5mm
  • Distal Balloon Length: 12mm
  • Catheter Length: 135cm
OCB4514BA

  • Coronary angioplasty balloon catheter, basic
  • Peripheral angioplasty balloon catheter, basic
FLASH Ostial System, Dual Balloon Angioplasty Catheter, 4.0mm x 12mm
Verge Medical, Inc.
OCB4014BA
In Commercial Distribution

  • M917OCB4014BA0 ()

  • Catheter Length: 135cm
  • Distal Balloon Length: 12mm
  • Distal Balloon Diameter: 4.0mm
OCB4014BA

  • Peripheral angioplasty balloon catheter, basic
  • Coronary angioplasty balloon catheter, basic
No Description
Biomet Orthopedics, LLC
904020
In Commercial Distribution

  • 70880304547291 ()
  • 00880304547292 ()
904020

  • Wire holding/twisting pliers
The Thermo-Electric Cooling (TEC) lid Module is used in conjunction with the CardioQuip Modular Cooler-Heater (MCH) to provide cooling to slow the melting of ice in the tank. The MCH is indicated to supply temperature-controlled water to heat exchange devices (e.g.; CPB Heat Exchangers, Cardioplegia Heat Exchangers and thermal regulating system blankets) to help control a patient's temperature during cardiopulmonary bypass procedures lasting not longer than six hours.
CARDIOQUIP, LLC
MCH-11TEC
In Commercial Distribution

  • 00860000846134 ()


  • Cardiopulmonary bypass system heating/cooling unit
The CardioQuip Refrigeration Module is a module of the CardioQuip Modular Cooler-Heater (MCH) which creates an ice block in the tank in order to lower the temperature of the water. The MCH is indicated to supply temperature-controlled water to heat exchange devices (e.g.; CPB Heat Exchangers, Cardioplegia Heat Exchangers and thermal regulating system blankets) to help control a patient's temperature during cardiopulmonary bypass procedures lasting not longer than six hours.
CARDIOQUIP, LLC
MCH-10RMS
In Commercial Distribution

  • 00860000846127 ()


  • Cardiopulmonary bypass system heating/cooling unit
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