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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 Atherectomy Catheter - 07290017590172

Catheter Eximo Atherectomy 2.35mm - Hydrophilic Coated
EXIMO MEDICAL LTD
EXM-4004-H000
In Commercial Distribution

  • 07290017590172 ()

  • Outer Diameter: 2.35 Millimeter
  • Length: 110 Centimeter
  • Lumen/Inner Diameter: 0.014 Inch


  • Atherectomy laser system beam guide-catheter, peripheral

Auryon Atherectomy Catheter - 07290017590165

Catheter Eximo Atherectomy 2mm - Hydrophilic Coated
EXIMO MEDICAL LTD
EXM-4003-H000
In Commercial Distribution

  • 07290017590165 ()

  • Outer Diameter: 2 Millimeter
  • Length: 135 Centimeter
  • Lumen/Inner Diameter: 0.014 Inch


  • Atherectomy laser system beam guide-catheter, peripheral

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

Affinity™ CP - 20643169785780

PUMP CBAP40 AFF CP CENTRIF CC US/CAN 4PK
MEDTRONIC, INC.
CBAP40
In Commercial Distribution

  • 20643169785780 ()
  • 00643169785786 ()


  • Cardiopulmonary bypass system centrifugal pump

Affinity™ CP - 20643169433254

PUMP AP40 AFFINITY CP CENTRIFUGAL NC
MEDTRONIC, INC.
AP40
In Commercial Distribution

  • 20643169433254 ()
  • 00643169433250 ()


  • Cardiopulmonary bypass system centrifugal pump

Affinity™ CP - 20643169433247

PUMP CBAP40 AFFINITY CP CENTRIFUGAL CC
MEDTRONIC, INC.
CBAP40
Not in Commercial Distribution

  • 20643169433247 ()
  • 00643169433243 ()


  • Cardiopulmonary bypass system centrifugal pump

Affinity™ CP - 20643169433230

PUMP BBAP40 AFFINITY CP CENTRIFUGAL BC
MEDTRONIC, INC.
BBAP40
In Commercial Distribution

  • 20643169433230 ()
  • 00643169433236 ()


  • Cardiopulmonary bypass system centrifugal pump

NES Reprocessed 0.9mm OTW Turbo Elite Laser Atherectomy Catheter - NRP368

The device is the Phillips 0.9mm OTW Turbo Elite Laser Atherectomy catheter that is reprocessed by Northeast Scientific, Inc. (NES).
NORTH EAST SCIENTIFIC INC
R-410-152
Not in Commercial Distribution

  • NRP368 ()

  • Catheter Working Length: 150 Centimeter
  • Lumen/Inner Diameter: .014 Inch
  • Guidewire Compatibility: 4 French
R-410-152

  • Atherectomy laser system beam guide-catheter, peripheral

NES Reprocessed 0.9mm RX Turbo Elite Laser Atherectomy Catheter - NRP130

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
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