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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No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
H3100ZP
In Commercial Distribution

  • 00840682123754 ()


  • Stationary gamma camera system
  • Full-body CT system
No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
H3100CF
In Commercial Distribution

  • 00840682123747 ()


  • Stationary gamma camera system
  • Full-body CT system
No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
H3100ZC
In Commercial Distribution

  • 00840682123730 ()


  • Full-body CT system
  • Stationary gamma camera system
No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
H3906AB
In Commercial Distribution

  • 00840682121446 ()


  • Stationary gamma camera system
  • Full-body CT system
No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
H3100AH
In Commercial Distribution

  • 00840682121194 ()


  • Full-body CT system
  • Stationary gamma camera system
No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
H3100AG
In Commercial Distribution

  • 00840682121187 ()


  • Stationary gamma camera system
  • Full-body CT system
No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
H3100JZ
In Commercial Distribution

  • 00840682115285 ()


  • Full-body CT system
  • Stationary gamma camera system
No Description
Hangwei GE Medical Systems Co., Ltd.
H2401DS
In Commercial Distribution

  • 00840682154338 ()


  • Stationary gamma camera system
  • Full-body CT system
No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
H3906ER
In Commercial Distribution

  • 00840682146401 ()


  • Full-body CT system
  • Stationary gamma camera system
StarGuide NM GANTRY MDR FINAL
G E MEDICAL SYSTEMS ISRAEL LTD.
H3911BJ
In Commercial Distribution

  • 00195278755544 ()
5842898-10

  • Stationary gamma camera system
  • Full-body CT system
StarGuide SW and Labels Upgrade
G E MEDICAL SYSTEMS ISRAEL LTD.
5962426
In Commercial Distribution

  • 00195278870490 ()
5962426

  • Stationary gamma camera system
  • Full-body CT system
IVD reagent kit containing 30 tests.
BIOFIRE DIAGNOSTICS, LLC
RFIT-ASY-0120
Not in Commercial Distribution

  • 00815381020147 ()
RFIT-ASY-0120

  • Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
ePlex Respiratory Panel Kit, 12 test, IVD
GENMARK DIAGNOSTICS, INC.
ePlex Respiratory Panel (RP)
In Commercial Distribution

  • 00857167005030 ()
EA001012

  • Multiple-genus respiratory virus antigen IVD, kit, multiplex
ePlex Sample Delivery Device RP Panel
GENMARK DIAGNOSTICS, INC.
ePlex Respiratory Panel (RP)
In Commercial Distribution

  • 00857167005023 ()
KT022006

  • Multiple-genus respiratory virus antigen IVD, kit, multiplex
Respiratory Panel Cartridge
GENMARK DIAGNOSTICS, INC.
ePlex Respiratory Panel (RP)
In Commercial Distribution

  • 00857167005016 ()
KT022287

  • Hepatitis G virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
QIAGEN GmbH
V1
In Commercial Distribution

  • 04053228033905 ()
691221

  • Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
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