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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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GeoSource - 00863003000343

Source Localization Software For Electroencephalograph Or Magnetoencephalograph Electroencephalograph.
ELECTRICAL GEODESICS, INC.
GeoSource 2.0
Not in Commercial Distribution

  • 00863003000343 ()


  • Electroencephalograph

Welch Allyn, Inc. - 00732094195408

Welch Allyn Connex Central Station Software; v 1.5
WELCH ALLYN, INC.
901066
In Commercial Distribution

  • 00732094195408 ()
1000994

  • Centralized patient monitor

Welch Allyn, Inc. - 00732094323993

Welch Allyn Diagnostic Cardiology Suite Spirometry; Software Only
WELCH ALLYN, INC.
901128
In Commercial Distribution

  • 00732094323993 ()
DCSS-SXA

  • Diagnostic spirometer, professional

Leica Biosystems CytoVision FISH review software (inc. dongle) - 00849832004318

Leica Biosystems CytoVision FISH review software (inc. dongle)
Leica Biosystems Richmond, Inc.
23SWR000FXX001
Not in Commercial Distribution

  • 00849832004318 ()

  • Device Size Text, specify:


  • Laboratory instrument/analyser application software IVD

Leica Biosystems CytoVision FISH Software License Activation Code - 00849832004301

Leica Biosystems CytoVision FISH Software License Activition Code
Leica Biosystems Richmond, Inc.
23SWR000FLX001
Not in Commercial Distribution

  • 00849832004301 ()

  • Device Size Text, specify:


  • Microscope objective

Leica Biosystems CytoVision CGH Software License Activation Code - 00849832004288

Leica Biosystems CytoVision CGH Software License Activation Code
Leica Biosystems Richmond, Inc.
23SWR000CGX001
Not in Commercial Distribution

  • 00849832004288 ()

  • Device Size Text, specify:


  • Laboratory instrument/analyser application software IVD

LiDCO - 05060110523054

Licence, Software, LiDCOrapid (Rapid, CNAP, BIS, Ext), Quarterly
LIDCO LIMITED
Li11076Q
In Commercial Distribution

  • 05060110523054 ()
Li11076Q

  • General-purpose multi-parameter bedside monitor

LiDCO - 05060110523047

Licence, Software, LiDCOrapid (Rapid, CNAP, BIS, Ext), Monthly
LIDCO LIMITED
Li11076M
In Commercial Distribution

  • 05060110523047 ()
Li11076M

  • General-purpose multi-parameter bedside monitor

LiDCO - 05060110523023

Licence, Software, LiDCOrapid (Rapid, CNAP, BIS, Ext), Annual
LIDCO LIMITED
Li11076A
In Commercial Distribution

  • 05060110523023 ()
Li11076A

  • General-purpose multi-parameter bedside monitor

OnPoint Surgical Cart - 00850051682485

OnPoint Surgical Cart (with pre-installed software) - 2 headsets
OnPoint Surgical, Inc.
1
In Commercial Distribution

  • 00850051682485 ()
NK0210301

  • Orthopaedic stereotactic surgery system

OnPoint Surgical Cart - 00850051682386

OnPoint Surgical Cart (with pre-installed software) - 3 headsets
OnPoint Surgical, Inc.
1
In Commercial Distribution

  • 00850051682386 ()
NK0210301

  • Orthopaedic stereotactic surgery system

OnPoint Surgical Cart - 00850051682010

OnPoint Surgical Cart (with pre-installed software) - 1 headset
OnPoint Surgical, Inc.
1
In Commercial Distribution

  • 00850051682010 ()
NK0210101

  • Orthopaedic stereotactic surgery system

RALS - 00850049633253

RALS test results capturing and data transferring software
Abbott Rapid Diagnostics Informatics, Inc.
8.4.1
In Commercial Distribution

  • 00850049633253 ()
8.4.1

  • Medical equipment clinical data interfacing software

RALS - 00850049633246

RALS test results capturing and data transferring software
Abbott Rapid Diagnostics Informatics, Inc.
8.4.0
In Commercial Distribution

  • 00850049633246 ()
8.4.0

  • Medical equipment clinical data interfacing software

RALS - 00850049633239

RALS test results capturing and data transferring software
Abbott Rapid Diagnostics Informatics, Inc.
8.3.0
In Commercial Distribution

  • 00850049633239 ()
8.3.0

  • Medical equipment clinical data interfacing software

RALS - 00850049633161

RALS test results capturing and data transferring software
Abbott Rapid Diagnostics Informatics, Inc.
8.2.0
In Commercial Distribution

  • 00850049633161 ()
8.2.0

  • Medical equipment clinical data interfacing software

RALS - 00850049633130

RALS test results capturing and data transferring software
Abbott Rapid Diagnostics Informatics, Inc.
8.1.1
In Commercial Distribution

  • 00850049633130 ()
8.1.1

  • Medical equipment clinical data interfacing software

RALS - 00850049633123

RALS test results capturing and data transferring software
Abbott Rapid Diagnostics Informatics, Inc.
8.1.0
In Commercial Distribution

  • 00850049633123 ()
8.1.0

  • Medical equipment clinical data interfacing software

RALS - 00850049633109

RALS test results capturing and data transferring software
Abbott Rapid Diagnostics Informatics, Inc.
8.0.1
In Commercial Distribution

  • 00850049633109 ()
8.0.1

  • Medical equipment clinical data interfacing software

RALS - 00850049633055

RALS test results capturing and data transferring software
Abbott Rapid Diagnostics Informatics, Inc.
8.0.0
In Commercial Distribution

  • 00850049633055 ()
8.0.0

  • Medical equipment clinical data interfacing software
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