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Company Name Brand Name GMDN Term 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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ePlex System - 00857167005030

ePlex Respiratory Panel Kit, 12 test, IVD
GENMARK DIAGNOSTICS, INC.
ePlex Respiratory Panel (RP)
In Commercial Distribution

  • 00857167005030 ()
EA001012

  • Multiple respiratory virus antigen IVD, kit, multiplex

ePlex System - 00857167005023

ePlex Sample Delivery Device RP Panel
GENMARK DIAGNOSTICS, INC.
ePlex Respiratory Panel (RP)
In Commercial Distribution

  • 00857167005023 ()
KT022006

  • Multiple respiratory virus antigen IVD, kit, multiplex

ePlex System - 00857167005016

Respiratory Panel Cartridge
GENMARK DIAGNOSTICS, INC.
ePlex Respiratory Panel (RP)
In Commercial Distribution

  • 00857167005016 ()
KT022287

  • Multiple respiratory virus antigen IVD, kit, multiplex

PhotoFix - B040PFP6X81

Decellularized Bovine Pericardium
GENESEE BIOMEDICAL, INC.
PFP6x8
In Commercial Distribution

  • B040PFP6X81 ()
N/A

  • Cardiovascular patch, animal-derived

830 to 870 DR Upgrade - 00840682146401

No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
H3906ER
In Commercial Distribution

  • 00840682146401 ()


  • Full-body CT system
  • Stationary gamma camera system

NMCT - 00840682140836

No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
870 DR
In Commercial Distribution

  • 00840682140836 ()


  • Stationary gamma camera system
  • Full-body CT system

NM - 00840682140829

No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
830
In Commercial Distribution

  • 00840682140829 ()


  • Stationary gamma camera system

NMCT - 00840682140775

No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
850
In Commercial Distribution

  • 00840682140775 ()


  • Full-body CT system
  • Stationary gamma camera system

NMCT - 00840682140751

No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
860
In Commercial Distribution

  • 00840682140751 ()


  • Full-body CT system
  • Stationary gamma camera system

Discovery - 00840682139403

No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
NMCT 670 ES
In Commercial Distribution

  • 00840682139403 ()


  • Full-body CT system
  • Stationary gamma camera system
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