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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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IntraSpin - D742ISD1100

IntraSpin System Dual 110 volts
INTRA-LOCK INTERNATIONAL, INC.
ISD110
In Commercial Distribution

  • D742ISD1100 ()
ISD110

  • Haematological concentrate system

IntraSpin - D742IS2200

IntraSpin 220 volts
INTRA-LOCK INTERNATIONAL, INC.
IS220
In Commercial Distribution

  • D742IS2200 ()
IS220

  • Haematological concentrate system

IntraSpin - D742IS1100

IntraSpin 110 volts
INTRA-LOCK INTERNATIONAL, INC.
IS110
In Commercial Distribution

  • D742IS1100 ()
IS110

  • Haematological concentrate system

IntraSpin - D742ISD2200

IntraSpin System Dual 220 volts
INTRA-LOCK INTERNATIONAL, INC.
ISD220
In Commercial Distribution

  • D742ISD2200 ()
ISD220

  • Haematological concentrate system

LeukoTrol - 15099590639396

Leuko-Trol RBC Control Cells
Beckman Coulter, Inc.
RBC Control
In Commercial Distribution

  • 15099590639396 ()
175658

  • Full blood count IVD, control

Counterweight, AXP - 00886368000520

AXP Accessory
Thermogenesis Corp.
8-5104
In Commercial Distribution

  • 00886368000520 ()
8-5104

  • Cryobiological storage container

AXP Adapter Set, Sorvall 11754/11297 - 00886368000445

No Description
Thermogenesis Corp.
8-5114
In Commercial Distribution

  • 00886368000445 ()
8-5114

  • Cryobiological storage container

PXP - 00886368000650

PXP Docking Station
Thermogenesis Corp.
80066
In Commercial Distribution

  • 00886368000643 ()
  • 00886368000650 ()


  • Blood centrifugation system containment kit

PXP - 00886368000636

PXP Control Module
Thermogenesis Corp.
80065
In Commercial Distribution

  • 00886368000629 ()
  • 00886368000636 ()


  • Blood centrifugation system containment kit

AutoXpress Platform Counterbalance CG - 00886368000568

No Description
Thermogenesis Corp.
8-5144
In Commercial Distribution

  • 00886368000568 ()
8-5144

  • Cryobiological storage container
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