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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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Site~Rite 8 Host System Software
Bard Access Systems, Inc.
SR8v2.2.0
In Commercial Distribution

  • 00801741219344 ()
SR8v2.2.0

  • General-purpose ultrasound imaging system
Site~Rite 8 Ultrasound Application Software
Bard Access Systems, Inc.
SR8 USv2.2.0
In Commercial Distribution

  • 00801741219252 ()
SR8 USv2.2.0

  • General-purpose ultrasound imaging system
Sherlock 3CG+ TCS Software Version 3.1.0
Bard Access Systems, Inc.
Sherlock 3CG+ TCS Software Version 3.1.0
In Commercial Distribution

  • 00801741188718 ()
Sherlock 3CG+ TCS Software Version 3.1.0

  • Central venous catheter navigation system, electrocardiographic/magnetic
Site~Rite 8 Ultrasound System Software
Bard Access Systems, Inc.
SR8v1.0.3
In Commercial Distribution

  • 00801741121449 ()
SR8v1.0.3

  • General-purpose ultrasound imaging system
Software Version 1.3 for Aurora Xi
Fresenius Kabi AG
1.3
In Commercial Distribution

  • 00810020440898 ()


  • Apheresis system
Aurora Plasmapheresis System Software Version 2.1
Fresenius Kabi AG
SW 2.1
In Commercial Distribution

  • 00810020440003 ()
  • 10810020440000 ()


  • Apheresis system
Cytomics FC 500 with CXP Software
Beckman Coulter, Inc.
UPS (CXP)
In Commercial Distribution

  • 15099590572839 ()
626553

  • Flow cytometry analyser IVD, semi-automated
SOFTWARE MMT-8061 INS PEN ANDROID APP
MEDTRONIC MINIMED, INC.
MMT-8061
In Commercial Distribution

  • 00763000489960 ()


  • Empty self-injector, mechanical
SOFTWARE MMT-8060 INSULIN PEN IOS APP
MEDTRONIC MINIMED, INC.
MMT-8060
In Commercial Distribution

  • 00763000489953 ()


  • Empty self-injector, mechanical
PillCam™ Web Software v9, USA
Given Imaging, Inc.
FGS-0639
In Commercial Distribution

  • 07290110360214 ()


  • Video capsule endoscopy system application software
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