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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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No Description
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
1250.ABD
In Commercial Distribution

  • 08717872000602 ()
  • 18717872000609 ()
1250.ABD

  • Surgical irrigation/aspiration tubing set
No Description
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
8110.DIL01
In Commercial Distribution

  • 08717872020952 ()
  • 18717872020959 ()
8110.DIL01

  • Surgical irrigation/aspiration tubing set
The Icy® Heat Exchange Catheter is a sterile, single use flexible 9.3 F catheter designed for placement in the inferior vena cava from an insertion site in the femoral vein.
Zoll Circulation, Inc.
IC-3893AE
In Commercial Distribution

  • 00849111075107 ()

  • Length: 38 Centimeter
  • Catheter Gauge: 9.3 French
8700-0657-40

  • Intravascular core temperature regulation system catheter
LifeSPARC Blood Pump Kit with 31 Fr ProtekDuo Veno-Venous Rapid Depolyment Cannula
CARDIACASSIST, INC.
5820-3631
Not in Commercial Distribution

  • 00814112020807 ()


  • Vascular dilator, single-use
  • Cardiopulmonary bypass system mounting unit
  • Cardiopulmonary bypass system centrifugal pump
  • Mobile extracorporeal gas exchange system catheter kit
LifeSPARC Blood Pump Kit with 31 Fr ProtekDuo Veno-Venous Cannula
CARDIACASSIST, INC.
5820-3118
Not in Commercial Distribution

  • 00814112020791 ()


  • Vascular dilator, single-use
  • Mobile extracorporeal gas exchange system catheter kit
  • Cardiopulmonary bypass system mounting unit
  • Cardiopulmonary bypass system centrifugal pump
LifeSPARC Blood Pump Kit with 29 Fr ProtekDuo Veno-Venous Cannula
CARDIACASSIST, INC.
5820-2916
Not in Commercial Distribution

  • 00814112020784 ()


  • Vascular dilator, single-use
  • Mobile extracorporeal gas exchange system catheter kit
  • Cardiopulmonary bypass system mounting unit
  • Cardiopulmonary bypass system centrifugal pump
No Description
BIOMET MICROFIXATION, INC
28-1010
In Commercial Distribution

  • 00841036041618 ()
28-1010

  • Surgical flat-nosed pliers
No Description
BIOMET MICROFIXATION, INC
09-0193
In Commercial Distribution

  • 00841036027650 ()
09-0193

  • Surgical flat-nosed pliers
No Description
BIOMET MICROFIXATION, INC
09-0192
In Commercial Distribution

  • 00841036027643 ()
09-0192

  • Surgical flat-nosed pliers
No Description
BIOMET MICROFIXATION, INC
09-0184
In Commercial Distribution

  • 00841036027612 ()
09-0184

  • Surgical flat-nosed pliers
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