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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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Phadia Information Data Manager Software Package
Phadia AB
12-3801-11
In Commercial Distribution

  • 07333066001012 ()
12-3801-11

  • Laboratory instrument/analyser application software IVD
Site~Rite 8 Software v. 3.0.1
Bard Access Systems, Inc.
SR8v3.0.1
In Commercial Distribution

  • 00801741225895 ()
SR8v3.0.1

  • General-purpose ultrasound imaging system
Site~Rite 8 Sherlock Application Software
Bard Access Systems, Inc.
Sherlockv3.1.1
In Commercial Distribution

  • 00801741219436 ()
Sherlockv3.1.1

  • Central venous catheter navigation system, electrocardiographic/magnetic
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
Site~Rite 8 Software v. 2.3.1
Bard Access Systems, Inc.
SR8v2.3.1
In Commercial Distribution

  • 00801741219382 ()
SR8v2.3.1

  • General-purpose ultrasound imaging system
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
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
SOFTWARE APP A610 DBS CLINICIAN V5.0
MEDTRONIC, INC.
A610
In Commercial Distribution

  • 00763000975029 ()


  • Multiple active implantable device programmer
POSTOPERATIVE TLHEX MODULE FOR ORTHONEXT SOFTWARE
ORTHOFIX SRL
1.0
In Commercial Distribution

  • 18052469476444 ()
TLHEXMODULESW

  • Radiological PACS software
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