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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Surgical Hand Tools
Thoratec Corporation
10002222US
In Commercial Distribution

10002222US

  • Cardiothoracic surgical procedure kit, non-medicated, reusable
LINX Esophagus Sizing Tools
Torax Medical, Inc.
LSSUS
In Commercial Distribution

  • 00855106005219 ()
  • 00855106005226 ()
LSSUS

  • Gastro-oesophageal antireflux prosthesis
ACCESSORY 3550-06 TUNNELING TOOLS
MEDTRONIC, INC.
3550-06
Not in Commercial Distribution

  • 10681490078013 ()


  • Subcutaneous tunneller, single-use
HM3 Surgical Hand Tools
Thoratec Corporation
10002222US
In Commercial Distribution

  • 00813024013259 ()
10002222US

  • Cardiothoracic surgical procedure kit, non-medicated, reusable
Esteem® Surgical Tools Kit
Envoy Medical Corporation
1216
In Commercial Distribution

  • 00812282020542 ()
701216-002

  • Fully-implantable middle ear implant system
The Pillar Variant Analysis Toolkit or PiVAT is an analytical software that comes on a preloaded workstation that is used to analyze sequencer data to generate applicable reports for the oncoReveal CDx
Pillar Biosciences, Inc.
SFW-2012 2.0
In Commercial Distribution

  • 00860001218275 ()
SFW-2012

  • Colorectal cancer genotyping IVD, kit, nucleic acid technique (NAT)
Programming Software
LIVANOVA USA, INC.
250 v8.1 (X5)
In Commercial Distribution

  • 05425025750191 ()


  • Vagus nerve electrical stimulation system programmer
Programming Software
LIVANOVA USA, INC.
250 v8.1 (X50)
In Commercial Distribution

  • 05425025750184 ()


  • Vagus nerve electrical stimulation system programmer
Fitting Software
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
35936
In Commercial Distribution

  • 09008737359362 ()


  • Audiometric/hearing device software
Fitting Software
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
31862
Not in Commercial Distribution

  • 09008737318628 ()


  • Audiometric/hearing device software
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