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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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Turbo-Elite™ - 00813132020101

Turbo-Elite™ Laser Atherectomy Catheter
Spectranetics Corporation
410-154AA
In Commercial Distribution

  • M204410154AA0 ()
  • 00813132020101 ()

  • Outer Diameter: 0.97 Millimeter
410-154

  • Atherectomy laser system beam guide-catheter, peripheral

Turbo-Elite™ - 00813132020095

Turbo-Elite™ Laser Atherectomy Catheter
Spectranetics Corporation
410-152AA
In Commercial Distribution

  • M204410152AA0 ()
  • 00813132020095 ()

  • Outer Diameter: 0.97 Millimeter
410-152

  • Atherectomy laser system beam guide-catheter, peripheral

TandemHeart - 00814112020043

TandemHeart blood pump
CARDIACASSIST, INC.
2100-0113
Not in Commercial Distribution

  • 00814112020043 ()


  • Cardiopulmonary bypass system centrifugal pump

Quantum Perfusion Centrifugal Blood Pump CP37 with Integrated Sensors - 18051160302663

No Description
SPECTRUM MEDICAL SRL
CP37V-VT
In Commercial Distribution

  • 18051160302663 ()


  • Cardiopulmonary bypass system centrifugal pump

Quantum Perfusion Centrifugal Blood Pump CP20 - 18051160302144

No Description
SPECTRUM MEDICAL SRL
CP20V-V0U
In Commercial Distribution

  • 18051160302144 ()


  • Cardiopulmonary bypass system centrifugal pump

Auryon Atherectomy Catheter - 07290017590332

Auryon Atherectomy Catheter 1.7mm OTW
EXIMO MEDICAL LTD
EXM-4012-0000
In Commercial Distribution

  • 07290017590332 ()

  • Outer Diameter: 1.7 Millimeter
  • Length: 150 Centimeter
EXM-4012-0000

  • Atherectomy laser system beam guide-catheter, peripheral

Auryon Atherectomy Catheter - 07290017590325

Auryon Atherectomy Catheter 1.7mm - Hydrophilic Coated
EXIMO MEDICAL LTD
EXM-4012-H000
In Commercial Distribution

  • 07290017590325 ()

  • Outer Diameter: 1.7 Millimeter
  • Length: 150 Centimeter
EXM-4012-H000

  • Atherectomy laser system beam guide-catheter, peripheral

Auryon Atherectomy Catheter - 07290017590318

Auryon Atherectomy Catheter 0.9mm Longer Length (XL) OTW
EXIMO MEDICAL LTD
EXM-4011-0000
In Commercial Distribution

  • 07290017590318 ()

  • Outer Diameter: 0.9 Millimeter
  • Length: 225 Centimeter
  • Lumen/Inner Diameter: 0.014 Inch
EXM-4011-0000

  • Atherectomy laser system beam guide-catheter, peripheral

Auryon Atherectomy Catheter - 07290017590301

Auryon Atherectomy Catheter 1.5mm Longer Length (XL) OTW
EXIMO MEDICAL LTD
EXM-4010-0000
In Commercial Distribution

  • 07290017590301 ()

  • Outer Diameter: 1.5 Millimeter
  • Length: 225 Centimeter
  • Lumen/Inner Diameter: 0.014 Inch
EXM-4010-0000

  • Atherectomy laser system beam guide-catheter, peripheral

Auryon Atherectomy Catheter - 07290017590295

Auryon Atherectomy Catheter 0.9mm Longer Length (XL) OTW - Hydrophilic Coating
EXIMO MEDICAL LTD
EXM-4011-H000
In Commercial Distribution

  • 07290017590295 ()

  • Outer Diameter: 0.9 Millimeter
  • Length: 225 Centimeter
  • Lumen/Inner Diameter: 0.014 Inch
EXM-4011-H000

  • Atherectomy laser system beam guide-catheter, peripheral
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