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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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SOD TUBE SIZING 6MM SLOTTED 2MM
Smith & Nephew, Inc.
3134163
Not in Commercial Distribution

  • 00885556600276 ()
3134163

  • Ligament graft sizer, noninvasive
REFURB CANN DRILL BIT 6MM
Smith & Nephew, Inc.
013542D
Not in Commercial Distribution

  • 00885556590591 ()
013542D

  • Ligament graft sizer, noninvasive
REFURBTUBESIZING 7.5MM
Smith & Nephew, Inc.
7207164D
Not in Commercial Distribution

  • 00885556568545 ()
7207164D

  • Ligament graft sizer, noninvasive
REFURBTUBESIZING 6.5MM
Smith & Nephew, Inc.
7207163D
Not in Commercial Distribution

  • 00885556568538 ()
7207163D

  • Ligament graft sizer, noninvasive
OCEL PACK
Cardinal Health 200, LLC
SOP45OCFC1
In Commercial Distribution

  • 50195594863973 ()
  • 10195594863975 ()
SOP45OCFC1

  • Decontamination floor mat, single-use
HIP PACK
Cardinal Health 200, LLC
SOP5BHPSJ8
In Commercial Distribution

  • 50195594881076 ()
  • 10195594881078 ()
SOP5BHPSJ8

  • Decontamination floor mat, single-use
The KODEX-EPD™ System is indicated for catheter-based cardiac electrophysiological (EP) procedures. The KODEX-EPD™ System provides information about the electrical activity of the heart and about catheter location during the procedure. The system can be used on patients who are eligible for a conventional electrophysiological procedure.
Philips Medical Systems Nederland B.V.
733015
Not in Commercial Distribution

  • 00884838095229 ()


  • Cardiac mapping system application software
DynaCAD is a MR image analysis software medical device that consists of MR Analysis Server, Viewer application, and Interventional Planning application.
Philips DS North America LLC
5
In Commercial Distribution

  • 00884838094857 ()
4598-016-98182, 3000-103-14352, 300011916421

  • MRI system application software
UroNav Version 3
Philips DS North America LLC
459801572611
In Commercial Distribution

  • 00884838091818 ()


  • Ultrasound imaging system application software
UroNav is a medical image processing device that provides image-guided intervention and diagnostic information, which guides interventional instrumentation to targets that have been defined by the physician.
Philips DS North America LLC
784026
In Commercial Distribution

  • 00884838089648 ()


  • Ultrasound imaging system application software
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