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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 - 00814112020043

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

  • 00814112020043 ()


  • Cardiopulmonary bypass system centrifugal pump

NES Reprocessed 2.0mm OTW Turbo Elite Laser Atherectomy Catheter - B227NRP3683

No Description
NORTH EAST SCIENTIFIC INC
R-420-006
In Commercial Distribution

  • B227NRP3683 ()
R-420-006

  • Atherectomy laser system beam guide-catheter, peripheral

NES Reprocessed 1.7mm OTW Turbo Elite Laser Atherectomy Catheter - B227NRP3682

No Description
NORTH EAST SCIENTIFIC INC
R-417-152
In Commercial Distribution

  • B227NRP3682 ()
R-417-152

  • Atherectomy laser system beam guide-catheter, peripheral

NES Reprocessed 1.4mm OTW Turbo Elite Laser Atherectomy Catheter - B227NRP3681

No Description
NORTH EAST SCIENTIFIC INC
R-414-151
In Commercial Distribution

  • B227NRP3681 ()
R-414-151

  • Atherectomy laser system beam guide-catheter, peripheral

NES Reprocessed 0.9mm OTW Turbo Elite Laser Atherectomy Catheter - B227NRP3680

No Description
NORTH EAST SCIENTIFIC INC
R-410-152
In Commercial Distribution

  • B227NRP3680 ()

  • Catheter Working Length: 150 Centimeter
  • Lumen/Inner Diameter: 0.014 Inch
  • Guidewire Compatibility: 4 French
R-410-152

  • Atherectomy laser system beam guide-catheter, peripheral

NES Reprocessed 2.0mm RX Turbo Elite Laser Atherectomy Catheter - B227NRP1303

No Description
NORTH EAST SCIENTIFIC INC
R-420-159
In Commercial Distribution

  • B227NRP1303 ()
R-420-159

  • Atherectomy laser system beam guide-catheter, peripheral

NES Reprocessed 1.7mm RX Turbo Elite Laser Atherectomy Catheter - B227NRP1302

No Description
NORTH EAST SCIENTIFIC INC
R-417-156
In Commercial Distribution

  • B227NRP1302 ()
R-417-156

  • Atherectomy laser system beam guide-catheter, peripheral

NES Reprocessed 1.4mm RX Turbo Elite Laser Atherectomy Catheter - B227NRP1301

No Description
NORTH EAST SCIENTIFIC INC
R-414-159
In Commercial Distribution

  • B227NRP1301 ()
R-414-159

  • Atherectomy laser system beam guide-catheter, peripheral

NES Reprocessed 0.9mm RX Turbo Elite Laser Atherectomy Catheter - B227NRP1300

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
In Commercial Distribution

  • B227NRP1300 ()

  • Catheter Working Length: 150 Centimeter
  • Lumen/Inner Diameter: 0.014 Inch
  • Guidewire Compatibility: 4 French
R-410-154

  • Atherectomy laser system beam guide-catheter, peripheral

PEDIMAG BLOOD PUMP - 07640135140634

No Description
Thoratec Switzerland GmbH
201-90052
In Commercial Distribution

  • 07640135140634 ()
201-90052

  • Cardiopulmonary bypass system centrifugal pump
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