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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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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
AR v3.0 Software kit
Given Imaging, Inc.
FGS-8030
In Commercial Distribution

  • 07290101365785 ()


  • Manometric gastrointestinal motility analysis system
Blue Sky Plan Software
BLUE SKY BIO LLC
5.0
In Commercial Distribution

  • 00810060226346 ()
BSP

  • Dental treatment application software
Blue Sky Plan Software
BLUE SKY BIO LLC
4.13
In Commercial Distribution

  • 00810060226063 ()
BSP

  • Dental treatment application software
iTero Lumina Pro Software
Align Technology, Inc.
225979
In Commercial Distribution

  • 00816063023067 ()


  • CAD/CAM software
Diana Web Server Software
ICU MEDICAL, INC.
DS2800-04-01
In Commercial Distribution

  • 00887709126770 ()
DS2800-04-01

  • Pharmaceutical fluid-dispensing system
Diana Workflow Management Software
ICU MEDICAL, INC.
DS2110-04-01
In Commercial Distribution

  • 00887709126749 ()
DS2110-04-01

  • Pharmaceutical fluid-dispensing system
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