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

  • 00814112020043 ()


  • Cardiopulmonary bypass system centrifugal pump
The device is the Phillips 0.9mm RX Turbo Elite Laser Atherectomy catheter that is reprocessed by Northeast Scientific, Inc. (NES).
NORTH EAST SCIENTIFIC INC
R-410-154
Not in Commercial Distribution

  • NRP130 ()

  • Catheter Working Length: 150 Centimeter
  • Lumen/Inner Diameter: .014 Inch
  • Guidewire Compatibility: 4 French


  • Atherectomy laser system beam guide-catheter, peripheral
No Description
Spectranetics Corporation
423-050
In Commercial Distribution

  • 00813132029951 ()

  • Outer Diameter: 2.3 Millimeter
  • Lumen/Inner Diameter: 0.018 Inch
  • Length: 125 Centimeter
423-050

  • Atherectomy laser system beam guide-catheter, peripheral
No Description
Spectranetics Corporation
420-050
In Commercial Distribution

  • 00813132029944 ()

  • Outer Diameter: 2.0 Millimeter
  • Lumen/Inner Diameter: 0.018 Inch
  • Length: 150 Centimeter
420-050

  • Atherectomy laser system beam guide-catheter, peripheral
No Description
Spectranetics Corporation
420-050
In Commercial Distribution

  • 00813132026783 ()

  • Outer Diameter: 2.0 Millimeter
  • Length: 150 Centimeter
420-050

  • Atherectomy laser system beam guide-catheter, peripheral
No Description
Spectranetics Corporation
423-050
In Commercial Distribution

  • 00813132026776 ()

  • Outer Diameter: 2.3 Millimeter
  • Length: 125 Centimeter
423-050

  • Atherectomy laser system beam guide-catheter, peripheral
Turbo-Power™ Laser Atherectomy Catheter
Spectranetics Corporation
423-050AA
In Commercial Distribution

  • 00813132025397 ()

  • Outer Diameter: 2.3 Millimeter
423-050

  • Atherectomy laser system beam guide-catheter, peripheral
Turbo-Power™ Laser Atherectomy Catheter
Spectranetics Corporation
420-050AA
In Commercial Distribution

  • 00813132025366 ()

  • Outer Diameter: 2.0 Millimeter
420-050

  • Atherectomy laser system beam guide-catheter, peripheral
Turbo-Power™ Laser Atherectomy Catheter
Spectranetics Corporation
420-050
In Commercial Distribution

  • 00813132024833 ()

  • Outer Diameter: 2.0 Millimeter
420-050

  • Atherectomy laser system beam guide-catheter, peripheral
No Description
Spectranetics Corporation
425-135-01
In Commercial Distribution

  • 00813132024819 ()

  • Outer Diameter: 2.6 Millimeter
  • Length: 112 Centimeter
425-135-01

  • Atherectomy laser system beam guide-catheter, peripheral
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