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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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ePlex System - 00857167005030

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 System - 00857167005023

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

ePlex System - 00857167005016

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)

c.cam Imaging System - 04056869001272

No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
08419009
In Commercial Distribution

  • 04056869001272 ()
8419009..

  • Stationary gamma camera system

ZIP Pen - 10614559105344

ZIP Pen Ergonomic Smoke Evacuation Pencil E-Z Clean, Non-Stick, PTFE Coated, 10 Ft (3.04m) Tubing, 22mm Connector
MEGADYNE MEDICAL PRODUCTS, INC.
252510EC
In Commercial Distribution

  • 10614559105344 ()
  • 30614559105348 ()
252510EC

  • Surgical plume evacuation system

Xpert Flu - 07332940001070

Xpert Flu kit; 10 test kit
CEPHEID
GXFLU-10A
Not in Commercial Distribution

  • 07332940001070 ()
GXFLU-10A

  • Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

WALLACH - 00888937013986

Biovac Smoke Evacuator (120 VAC)
Coopersurgical, Inc.
909070
In Commercial Distribution

  • 00888937013986 ()


  • Surgical plume evacuation system

VisiClear - 00815198012076

Surgical Smoke Evacuator
Buffalo Filter
VC120NF
Not in Commercial Distribution

  • 00815198012076 ()
  • 10815198012073 ()


  • Surgical plume evacuation system

VisiClear - 00815198012069

Surgical Smoke Evacuator with Filter
Buffalo Filter
VC120
Not in Commercial Distribution

  • 00815198012069 ()
  • 10815198012066 ()


  • Surgical plume evacuation system

ViroVac - 00815198011994

Surgical Smoke Evacuator
Buffalo Filter
DKVV120
Not in Commercial Distribution

  • 00815198011994 ()


  • Surgical plume evacuation system
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