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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OCS Liver Gas Cylinder, Refill
TRANSMEDICS, INC.
3406
In Commercial Distribution

  • B00946653 ()
  • B00946650 ()

  • Length: 18 Inch
  • Width: 4 Inch
  • Height: 4 Inch
3406

  • Donor-organ preservation/transport system gas refillable cylinder
OCS Liver Gas Cylinder
TRANSMEDICS, INC.
3406
In Commercial Distribution

  • B00946643 ()
  • B00946640 ()

  • Length: 18 Inch
  • Width: 4 Inch
  • Height: 4 Inch
3406

  • Donor-organ preservation/transport system gas refillable cylinder
OCS Liver Perfusion Termination Set
TRANSMEDICS, INC.
3421
In Commercial Distribution

  • B00944915 ()
  • B00944843 ()

  • Length: 18 Inch
  • Width: 12 Inch
  • Height: 4 Inch
3421

  • Donor-organ preservation/transport perfusion initiation/termination set
OCS Liver Instrumentation Tool Set
TRANSMEDICS, INC.
3401
In Commercial Distribution

  • B00944905 ()
  • B00944833 ()

  • Length: 18 Inch
  • Width: 12 Inch
  • Height: 4 Inch
3401

  • Donor-organ preservation/transport perfusion set connection kit
PRGRMR 7438 PATIENT SOLETRA EZ
MEDTRONIC, INC.
7438
In Commercial Distribution

  • 00613994877284 ()


  • Multiple active implantable device programmer
PRGRMR 7436 PATIENT KINETRA EZ
MEDTRONIC, INC.
7436
In Commercial Distribution

  • 00613994877277 ()


  • Multiple active implantable device programmer
FS Libre Sensor Kit
ABBOTT DIABETES CARE INC
71942
Not in Commercial Distribution

  • 30357599000852 ()
  • 00357599000851 ()
  • 57599-0000-85 ()
71942

  • Percutaneous interstitial-fluid glucose monitoring system, electrochemical
No Description
BIOTRONIK SE & Co. KG
BIOwand
In Commercial Distribution

  • 04035479166120 ()
445633

  • Spinal cord/peripheral nerve implantable analgesic electrical stimulation system programmer
No Description
BIOTRONIK SE & Co. KG
424723
In Commercial Distribution

  • 04035479163068 ()
424723

  • Cardiac pulse generator programmer
No Description
BIOTRONIK SE & Co. KG
429748
In Commercial Distribution

  • 04035479157098 ()
429748

  • Electrocardiographic lead set, reusable
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