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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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SiteRite 9 Sherlock Software
Bard Access Systems, Inc.
Sherlockv3.3.0
In Commercial Distribution

  • 00801741219214 ()
Sherlockv3.3.0

  • General-purpose ultrasound imaging system
  • Central venous catheter navigation system, electrocardiographic/magnetic
Blue Sky Plan Software
BLUE SKY BIO LLC
4.13
In Commercial Distribution

  • 00810060226063 ()
BSP

  • Dental treatment application software
Cardiac PET Processing Software
Bracco Diagnostics Inc.
1.00
In Commercial Distribution

  • 30815112020584 ()
001771

  • Image segmentation application software
AR v3.0 Software kit
Given Imaging, Inc.
FGS-8030
In Commercial Distribution

  • 07290101365785 ()


  • Manometric gastrointestinal motility analysis system
ORTHONEXT SOFTWARE VERSION 2.1
ORTHOFIX SRL
2.1
In Commercial Distribution

  • 18059015375831 ()
ORTHONEXTSW2.1

  • Radiological PACS software
ManoView ESO Software v3.3
Given Imaging, Inc.
FGS-0628
In Commercial Distribution

  • 07290101369578 ()


  • Manometric gastrointestinal motility analysis system
PillCam Software v9.0, USA
Given Imaging, Inc.
FGS-0612
In Commercial Distribution

  • 07290101366751 ()


  • Video capsule endoscopy system application software
CLT v3.0 software upgrade
Given Imaging, Inc.
FGS-0580
In Commercial Distribution

  • 07290101366102 ()


  • Manometric gastrointestinal motility analysis system
v3.0 software kit upgrade
Given Imaging, Inc.
FGS-0573
In Commercial Distribution

  • 07290101365945 ()


  • Manometric gastrointestinal motility analysis system
CLT v3.0 software kit
Given Imaging, Inc.
FGS-0572
In Commercial Distribution

  • 07290101365938 ()


  • Manometric gastrointestinal motility analysis system
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