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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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ARP Rx100 - M7570010320

Electrical Muscle Stimulator
ARP MANUFACTURING LLC
Rx100
In Commercial Distribution

  • M7570010320 ()


  • Physical therapy transcutaneous electrical stimulation system, line-powered

QuickScan (Windows 2000) Software, Version 2.02, and Key - M52516730010

No Description
HELENA LABORATORIES CORPORATION
1673001
In Commercial Distribution

  • M52516730010 ()


  • Densitometry analyser IVD

Premier Heart MCG - B320CF190

Premier Heart MCG Field Unit, Model CF19
PREMIER HEART, LLC
CF19
In Commercial Distribution

  • B320CF190 ()
CF19

  • Cardiopulmonary physiological parameter analysis software
  • Electrocardiograph, professional, multichannel

Surgical Tools for Erythrocyte and Marrow Preparation Kit - M896MAR01O250

Sterile Disposable Kit containing single-patient-use components necessary for each platelet separation procedure with the MAGELLAN® Autologous Platelet Separator Instrument.
ARTERIOCYTE MEDICAL SYSTEMS, INC.
MAR01-O-25
In Commercial Distribution

  • M896MAR01O250 ()
  • M896MAR01O251 ()
MAR01-O-25

  • Haematological concentrate system preparation kit, platelet concentration

Surgical Tools for Erythrocyte and Marrow Preparation Kit - M896MAR01O1050

Sterile Disposable Kit containing single-patient-use components necessary for each platelet separation procedure with the MAGELLAN® Autologous Platelet Separator Instrument.
ARTERIOCYTE MEDICAL SYSTEMS, INC.
MAR01-O-105
In Commercial Distribution

  • M896MAR01O1051 ()
  • M896MAR01O1050 ()


  • Haematological concentrate system preparation kit, platelet concentration

MAGELLAN Surgical Tools for Erythrocyte & Marrow Preparation Kit - M896MAR01JPN800

No Description
ARTERIOCYTE MEDICAL SYSTEMS, INC.
MAR01-JPN-80
In Commercial Distribution

  • M896MAR01JPN800 ()


  • Haematological concentrate system preparation kit, platelet concentration

MAGELLAN Surgical Tools for Erythrocyte & Marrow Preparation Kit - M896MAR01JPN450

No Description
ARTERIOCYTE MEDICAL SYSTEMS, INC.
MAR01-JPN-45
In Commercial Distribution

  • M896MAR01JPN450 ()


  • Haematological concentrate system preparation kit, platelet concentration

MAGELLAN Surgical Tools for Erythrocyte & Marrow Preparation Kit - M896MAR01JPN250

No Description
ARTERIOCYTE MEDICAL SYSTEMS, INC.
MAR01-JPN-25
In Commercial Distribution

  • M896MAR01JPN250 ()


  • Haematological concentrate system preparation kit, platelet concentration

MAGELLAN Surgical Tools for Erythrocyte & Marrow Preparation Kit - M896MAR01JPN1050

No Description
ARTERIOCYTE MEDICAL SYSTEMS, INC.
MAR01-JPN-105
In Commercial Distribution

  • M896MAR01JPN1050 ()


  • Haematological concentrate system preparation kit, platelet concentration

MAGELLAN Surgical Tools for Erythrocyte & Marrow Preparation Kit - M896MAR01ATS0

Sterile Disposable Kit Containing single patient-use components necessary for each platelet separation procedure with the MAGELLAN® Autologous Platelet Separator Instrument.
ARTERIOCYTE MEDICAL SYSTEMS, INC.
MAR01-ATS
In Commercial Distribution

  • M896MAR01ATS0 ()
  • M896MAR01ATS1 ()
MAR01-ATS

  • Haematological concentrate system preparation kit, platelet concentration
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