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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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Auryon Laser System 100-120 Vac
EXIMO MEDICAL LTD
EXM-2001-1100
In Commercial Distribution

  • 07290017590110 ()
  • 17290017590131 ()
EXM-2001-1100

  • Atherectomy laser system beam guide-catheter, peripheral
Auryon Atherectomy Catheter 2.0 mm OTW
EXIMO MEDICAL LTD
EXM-4003-0000
In Commercial Distribution

  • 07290017590080 ()

  • Outer Diameter: 2.04 Millimeter
  • Length: 135 Centimeter
  • Lumen/Inner Diameter: 0.014 Inch
EXM-4003-0000

  • Atherectomy laser system beam guide-catheter, peripheral
Auryon Atherectomy Catheter 1.5 mm OTW
EXIMO MEDICAL LTD
EXM-4001-0000
In Commercial Distribution

  • 07290017590066 ()

  • Outer Diameter: 1.51 Millimeter
  • Length: 150 Centimeter
  • Lumen/Inner Diameter: 0.014 Inch
EXM-4001-0000

  • Atherectomy laser system beam guide-catheter, peripheral
2.35 mm OTW B-Laser™ catheter For Infra Inguinal Atherectomy
EXIMO MEDICAL LTD
EXM-4004-0000
Not in Commercial Distribution

  • 17290017590032 ()
  • 07290017590035 ()


  • Atherectomy laser system beam guide-catheter, peripheral
0.9 mm OTW B-Laser™ catheter For Infra Inguinal Atherectomy
EXIMO MEDICAL LTD
EXM-4002-0000
Not in Commercial Distribution

  • 17290017590018 ()
  • 07290017590011 ()


  • Atherectomy laser system beam guide-catheter, peripheral
1.5 mm OTW B-Laser™ catheter For Infra Inguinal Atherectomy
EXIMO MEDICAL LTD
EXM-4001-0000
Not in Commercial Distribution

  • 17290017590001 ()
  • 07290017590004 ()


  • Atherectomy laser system beam guide-catheter, peripheral
PUMP CBAP40 AFFINITY CP CENTRIFUGAL CC
MEDTRONIC, INC.
CBAP40
In Commercial Distribution

  • 20763000074412 ()
  • 00763000074418 ()


  • Cardiopulmonary bypass system centrifugal pump
No Description
SPECTRUM MEDICAL SRL
CP37V-VT
In Commercial Distribution

  • 18051160302663 ()


  • Cardiopulmonary bypass system centrifugal pump
No Description
SPECTRUM MEDICAL SRL
CP20V-V0U
In Commercial Distribution

  • 18051160302144 ()


  • Cardiopulmonary bypass system centrifugal pump
Percutaneous Catheter
Catheter Precision, Inc.
101
In Commercial Distribution

  • 00842362100031 ()


  • Atherectomy laser system beam guide-catheter, peripheral
ET TUBE, EXCHANGER, ETX, 35 - 41 FR
TELEFLEX INCORPORATED
IPN044923
In Commercial Distribution

  • 24026704588620 ()
  • 04026704588626 ()
  • 44026704588624 ()

  • Length: 1000 Millimeter
  • Sheridan E.T.X. Endobronchial Tube Exchanger
5-24105

  • Endotracheal tube guide, single-use
ADAPTER AP40AST AFFINITY CP WW 31L
MEDTRONIC, INC.
AP40AST
In Commercial Distribution

  • 00763000301323 ()

  • Outer Diameter: 94.0 Millimeter
  • Height: 28.0 Millimeter
  • Weight: 315.0 Gram


  • Cardiopulmonary bypass system centrifugal pump
Aintree Intubation Catheter with Rapi-Fit Adapter
COOK INCORPORATED
G57626
In Commercial Distribution

  • 00827002576261 ()
C-CAE-19.0-56-AIC-01

  • Endotracheal tube guide, single-use
No Description
SPECTRUM MEDICAL SRL
CP20V-VT
In Commercial Distribution

  • 08051160300846 ()


  • Cardiopulmonary bypass system centrifugal pump
No Description
SPECTRUM MEDICAL SRL
CP22V-VT
In Commercial Distribution

  • 08051160300624 ()


  • Cardiopulmonary bypass system centrifugal pump
No Description
SPECTRUM MEDICAL SRL
CP37V-V0
In Commercial Distribution

  • 28051160300611 ()
  • 08051160300617 ()


  • Cardiopulmonary bypass system centrifugal pump
No Description
SPECTRUM MEDICAL SRL
CP22V-V0
In Commercial Distribution

  • 28051160300604 ()
  • 08051160300600 ()


  • Cardiopulmonary bypass system centrifugal pump
No Description
Merit Medical Systems, Inc.
00884450021637
In Commercial Distribution

  • 10884450021634 ()
  • 00884450021637 ()

  • Configuration-Standard J 3.0 mm Tip Exchange
  • Tip Shape-3 mm J-Tip
  • Length-260 cm (102")
  • Tip Shape-3 mm J-Tip; Configuration-Standard J 3.0 mm Tip Exchange; Tip Shape-3 mm J-Tip; Length-260 cm (102")
  • Length-260 cm (102"); Configuration-Standard J 3.0 mm Tip Exchange; Tip Shape-3 mm J-Tip; Length-260 cm (102")
IQR35F260J3/B

  • Cardiac/peripheral vascular guidewire, single-use
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
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
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