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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 Tandem™ - 00813132020231

Turbo-Tandem™ Laser Guide Catheter with Laser Atherectomy Catheter
Spectranetics Corporation
472-110AA
In Commercial Distribution

  • M204472110AA0 ()
  • 00813132020231 ()

  • Length: 110 Centimeter
472-110

  • Atherectomy laser system beam guide-catheter, peripheral

Turbo Elite™ - 00813132020217

Turbo-Elite™ Laser Atherectomy Catheter
Spectranetics Corporation
425-135-01AA
In Commercial Distribution

  • 00813132020217 ()
  • M20442513501AA0 ()

  • Outer Diameter: 2.6 Millimeter
425-135-01

  • Atherectomy laser system beam guide-catheter, peripheral

Turbo Elite™ - 00813132020194

Turbo-Elite™ Laser Atherectomy Catheter
Spectranetics Corporation
423-135-01AA
In Commercial Distribution

  • M20442313501AA0 ()
  • 00813132020194 ()

  • Outer Diameter: 2.3 Millimeter
423-135-01

  • Atherectomy laser system beam guide-catheter, peripheral

Turbo-Elite™ - 00813132020187

Turbo-Elite™ Laser Atherectomy Catheter
Spectranetics Corporation
425-011AA
In Commercial Distribution

  • M204425011AA0 ()
  • 00813132020187 ()

  • Outer Diameter: 2.6 Millimeter
425-011

  • Atherectomy laser system beam guide-catheter, peripheral

Turbo-Elite™ - 00813132020170

Turbo-Elite™ Laser Atherectomy Catheter
Spectranetics Corporation
423-001AA
In Commercial Distribution

  • M204423001AA0 ()
  • 00813132020170 ()

  • Outer Diameter: 2.3 Millimeter
423-001

  • Atherectomy laser system beam guide-catheter, peripheral

Turbo-Elite™ - 00813132020163

Turbo-Elite™ Laser Atherectomy Catheter
Spectranetics Corporation
420-159AA
In Commercial Distribution

  • M204420159AA0 ()
  • 00813132020163 ()

  • Outer Diameter: 2.0 Millimeter
420-159

  • Atherectomy laser system beam guide-catheter, peripheral

Turbo-Elite™ - 00813132020156

Turbo-Elite™ Laser Atherectomy Catheter
Spectranetics Corporation
420-006AA
In Commercial Distribution

  • M204420006AA0 ()
  • 00813132020156 ()

  • Outer Diameter: 2.0 Millimeter
420-006

  • Atherectomy laser system beam guide-catheter, peripheral

Turbo-Elite™ - 00813132020149

Turbo-Elite™ Laser Atherectomy Catheter
Spectranetics Corporation
417-156AA
In Commercial Distribution

  • M204417156AA0 ()
  • 00813132020149 ()

  • Outer Diameter: 1.75 Millimeter
417-156

  • Atherectomy laser system beam guide-catheter, peripheral

Turbo-Elite™ - 00813132020132

Turbo-Elite™ Laser Atherectomy Catheter
Spectranetics Corporation
417-152AA
In Commercial Distribution

  • M204417152AA0 ()
  • 00813132020132 ()

  • Outer Diameter: 1.73 Millimeter
417-152

  • Atherectomy laser system beam guide-catheter, peripheral

Turbo-Elite™ - 00813132020125

Turbo-Elite™ Laser Atherectomy Catheter
Spectranetics Corporation
414-159AA
In Commercial Distribution

  • M204414159AA0 ()
  • 00813132020125 ()

  • Outer Diameter: 1.45 Millimeter
414-159

  • Atherectomy laser system beam guide-catheter, peripheral

Turbo-Elite™ - 00813132020118

Turbo-Elite™ Laser Atherectomy Catheter
Spectranetics Corporation
414-151AA
In Commercial Distribution

  • M204414151AA0 ()
  • 00813132020118 ()

  • Pore Size: 1.40 Millimeter
414-151

  • Atherectomy laser system beam guide-catheter, peripheral

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

Turbo Tandem™ - M2044821100

Turbo-Tandem™ Laser Guide Catheter with Laser Atherectomy Catheter
Spectranetics Corporation
482-110
Not in Commercial Distribution

  • M2044821100 ()

  • Length: 110 Centimeter
482-110

  • Atherectomy laser system beam guide-catheter, peripheral

Turbo Tandem™ - M2044721100

Turbo-Tandem™ Laser Guide Catheter with Laser Atherectomy Catheter
Spectranetics Corporation
472-110
Not in Commercial Distribution

  • M2044721100 ()

  • Length: 110 Centimeter
472-110

  • Atherectomy laser system beam guide-catheter, peripheral

Turbo Elite™ - M204425135010

Turbo-Elite™ Laser Atherectomy Catheter
Spectranetics Corporation
425-135-01
Not in Commercial Distribution

  • M204425135010 ()

  • Outer Diameter: 2.6 Millimeter
425-135-01

  • Atherectomy laser system beam guide-catheter, peripheral

Turbo-Elite™ - M2044250010

Turbo-Elite™ Laser Atherectomy Catheter
Spectranetics Corporation
425-011
Not in Commercial Distribution

  • M2044250010 ()

  • Outer Diameter: 2.6 Millimeter
425-011

  • Atherectomy laser system beam guide-catheter, peripheral
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