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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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StealthStation Treon AxiEM - 00613994097262

AXIEM KIT 9732661 PORTABLE 110
MEDTRONIC NAVIGATION, INC.
9732661
In Commercial Distribution

  • 00613994097262 ()


  • Multi-purpose stereotactic surgery system

N/A - 00613994097170

BUR 31135051 5MM FINE DIAMOND STD LENGTH
MEDTRONIC XOMED, INC.
31135051
In Commercial Distribution

  • 00613994097170 ()

  • Outer Diameter: 5.0 Millimeter


  • Orthopaedic bur, reusable

SHERPA NX BALANCED - 00613994096593

CATHETER SB8JR40 SB 8F 100CM JR40
MEDTRONIC, INC.
SB8JR40
Not in Commercial Distribution

  • 00613994096593 ()

  • Curve JR4.0
  • Length: 100.0 Centimeter
  • Catheter Gauge: 8.0 French


  • Vascular guide-catheter, single-use

AFFINITY® - 00613994094346

FILTER 61399409434 AFFINITY 6CA ARFIL20M
MEDTRONIC, INC.
61399409434
In Commercial Distribution

  • 50613994094341 ()
  • 00613994094346 ()

  • Pore Size: 20.0 Micrometer


  • Cardiopulmonary bypass system filter, arterial blood line

AFFINITY® - 00613994011534

FILTER 61399401153 AFFINITY 6CA ART 352
MEDTRONIC, INC.
61399401153
In Commercial Distribution

  • 50613994011539 ()
  • 00613994011534 ()

  • Pore Size: 38.0 Micrometer


  • Cardiopulmonary bypass system filter, arterial blood line

AFFINITY® - 00613994011244

FILTER 61399401124 AFFINITY 6CA ART 351
MEDTRONIC, INC.
61399401124
In Commercial Distribution

  • 50613994011249 ()
  • 00613994011244 ()

  • Pore Size: 38.0 Micrometer


  • Cardiopulmonary bypass system filter, arterial blood line

BIOtherm™ - 00613994009647

EXCHANGER 61399400964 12CA HT BIOTHERM
MEDTRONIC, INC.
61399400964
Not in Commercial Distribution

  • 00613994009647 ()


  • Cardiopulmonary bypass system heat exchanger, reusable

ECMO - 00613994008916

OXYGENATOR 61399400891 6CA 1500 ECMO
MEDTRONIC, INC.
61399400891
In Commercial Distribution

  • 50613994008911 ()
  • 00613994008916 ()


  • Extracorporeal membrane oxygenator

ECMO - 00613994008893

OXYGENATOR 61399400889 6PK 0800 ECMO
MEDTRONIC, INC.
61399400889
Not in Commercial Distribution

  • 50613994008898 ()
  • 00613994008893 ()


  • Extracorporeal membrane oxygenator

ECMOtherm- II™ - 00613994008701

EXCHANGER 61399400870 12CA EMOTRMII HT
MEDTRONIC, INC.
61399400870
Not in Commercial Distribution

  • 00613994008701 ()


  • Cardiopulmonary bypass system heat exchanger, reusable
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