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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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Disposable EVA Double Irrigation Line with Air Exchange - 08717872020952

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

ICY® Intravascular Heat Exchange Catheter Kit (Heparin) - 00849111075107

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

Pointe Scientific, Inc. - 00811727011336

Controls for use in the quantitative determination of human glycohemoglobin (HbA1) in blood by cation exchange resin. 2 x 1.0ml
POINTE SCIENTIFIC, INC.
G7540-2
In Commercial Distribution

  • 00811727011336 ()
G7540-2

  • Glycated haemoglobin (HbA1c) IVD, control

LifeSPARC - 00814112020807

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 - 00814112020791

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 - 00814112020784

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

Voca - 00781096541676

Spectacle Frame, Size 65-21-127
MCGEE GROUP, INC., THE
VC Kong Slate Black/Smoke Red
In Commercial Distribution

  • 00781096541676 ()
VCKONGSBSROOSND

  • Spectacle frame

Olympus - 14042761062913

Sealing cap, for WA22870A, 5 pcs.
OLYMPUS Winter & Ibe GmbH
WA22880A
Not in Commercial Distribution

  • 14042761062913 ()
  • 04042761062916 ()
WA22880A

  • Endoscope working-channel valve, single-use

Olympus - 14042761062555

sealing cap, 0.7 mm, for WA63817A,, grey, 20 pcs.
OLYMPUS Winter & Ibe GmbH
WA63821A
In Commercial Distribution

  • 14042761062555 ()
  • 04042761062558 ()
WA63821A

  • Endoscope working-channel valve, single-use

Olympus - 14042761001493

No Description
OLYMPUS Winter & Ibe GmbH
A0344
Not in Commercial Distribution

  • 14042761001493 ()
  • 04042761001496 ()
A0344

  • Endoscope working-channel valve, single-use
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