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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

870ES to 870 DR Upgrade - 00840682145947

No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
H3906EF
In Commercial Distribution

  • 00840682145947 ()


  • Stationary gamma camera system
  • Full-body CT system

860ES to 860 Upgrade - 00840682145930

No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
H3908AX
In Commercial Distribution

  • 00840682145930 ()


  • Full-body CT system
  • Stationary gamma camera system

870DR to 870 CZT Upgrade - 00840682145725

No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
H3906DX
In Commercial Distribution

  • 00840682145725 ()


  • Stationary gamma camera system
  • Full-body CT system

830 to 850 Upgrade - 00840682145527

No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
H3907AN
In Commercial Distribution

  • 00840682145527 ()


  • Stationary gamma camera system
  • Full-body CT system

850ES to 850 Upgrade - 00840682145510

No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
H3907AR
In Commercial Distribution

  • 00840682145510 ()


  • Full-body CT system
  • Stationary gamma camera system
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