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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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Kaluza C - 15099590705084

Kaluza C Perpetual License
Beckman Coulter, Inc.
Perpetual License
In Commercial Distribution

  • 15099590705084 ()
C10574

  • Laboratory instrument/analyser application software IVD

Navios EX - 15099590683269

NAVIOS EX OFFLINE ACQ 5 USERS SOFTWARE V2.0 WIN 7
BECKMAN COULTER IRELAND INC.
OFFLINE ACQ 5 USERS SOFTWARE V2.0 WIN 7
In Commercial Distribution

  • 15099590683269 ()
B91239

  • Laboratory instrument/analyser application software IVD

LENS CONNECTED TOWER APPLICATION - 00885556778777

LENS CONNECTED TOWER APPLICATION
Smith & Nephew, Inc.
72205347
In Commercial Distribution

  • 00885556778777 ()
72205347

  • Operating room audiovisual data/device management system application software

INTELLIO Tablet - 00885556813683

INTELLIO TABLET
Smith & Nephew, Inc.
72205455
In Commercial Distribution

  • 00885556813683 ()
72205455

  • Operating room audiovisual data/device management system application software

Navios EX - 15099590683252

NAVIOS EX OFFLINE ACQ SINGLE USER SOFTWARE V2.0 WIN 7
BECKMAN COULTER IRELAND INC.
OFFLINE ACQ SINGLE USER SOFTWARE V2.0 WIN 7
In Commercial Distribution

  • 15099590683252 ()
B91238

  • Laboratory instrument/analyser application software IVD

Navios EX - 15099590683245

NAVIOS EX ACQUISITION NEW USER SOFTWARE V2.0 WIN 7
BECKMAN COULTER IRELAND INC.
ACQUISITION NEW USER SOFTWARE V2.0 WIN 7
In Commercial Distribution

  • 15099590683245 ()
B91237

  • Laboratory instrument/analyser application software IVD

reticONE - 15099590572686

reticONE System
Beckman Coulter, Inc.
6915048
In Commercial Distribution

  • 15099590572686 ()
6915048

  • Laboratory instrument/analyser application software IVD

tetraCXP SW - 15099590547240

tetraCXP System
Beckman Coulter, Inc.
629638
In Commercial Distribution

  • 15099590547240 ()
629638

  • Laboratory instrument/analyser application software IVD

uWS - 06971576834143

No Description
Shanghai United Imaging Healthcare Co., Ltd.
uWS-MR
In Commercial Distribution

  • 06971576834143 ()


  • MRI system application software

PRIMA - 15420045504691

Prima
Hologic, Inc.
PRIMA
Not in Commercial Distribution

  • 15420045504691 ()


  • Laboratory instrument/analyser application software IVD
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