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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IQ ANALYTICS 5 USER LICENSE PACK
PENTAX OF AMERICA, INC.
M70229
In Commercial Distribution

  • 04961333243907 ()
  • 14961333243904 ()


  • Radiology information system
HITACHI SONOELASTOG SOFTWR/HV PREIRUS-B
PENTAX OF AMERICA, INC.
M70228
In Commercial Distribution

  • 04961333243891 ()


  • Diagnostic imaging telemedicine system
MICROSOFT SQL RUNTIME
PENTAX OF AMERICA, INC.
M70227
In Commercial Distribution

  • 04961333243884 ()


  • Radiology information system
MICROSOFT SQL STANDARD EDITION
PENTAX OF AMERICA, INC.
M70226
In Commercial Distribution

  • 04961333243877 ()


  • Radiology information system
MICROSOFT SQL ENTERPRISE EDITION
PENTAX OF AMERICA, INC.
M70225
In Commercial Distribution

  • 04961333243860 ()


  • Radiology information system
PATHOLOGY SYSTEM INTERFACE
PENTAX OF AMERICA, INC.
M70224-UP
In Commercial Distribution

  • 04961333243853 ()


  • Radiology information system
PATHOLOGY SYSTEM INTERFACE
PENTAX OF AMERICA, INC.
M70224
In Commercial Distribution

  • 04961333243846 ()


  • Radiology information system
VITALS MONITOR INTERFACE
PENTAX OF AMERICA, INC.
M70223-UP
In Commercial Distribution

  • 04961333243839 ()


  • Radiology information system
VITALS MONITOR INTERFACE
PENTAX OF AMERICA, INC.
M70223
In Commercial Distribution

  • 04961333243822 ()


  • Radiology information system
HL7 OUTBOUND INTERFACE (UNC/PDF)
PENTAX OF AMERICA, INC.
M70222-UP
In Commercial Distribution

  • 04961333243815 ()


  • Radiology information system
HL7 OUTBOUND INTERFACE UNC/PDF ADD-ON
PENTAX OF AMERICA, INC.
M70222
In Commercial Distribution

  • 04961333243808 ()


  • Radiology information system
HL7 OUTBOUND INTERFACE (ORU)
PENTAX OF AMERICA, INC.
M70221-UP
In Commercial Distribution

  • 04961333243792 ()


  • Radiology information system
HL7 OUTBOUND INTERFACE (ORU)
PENTAX OF AMERICA, INC.
M70221
In Commercial Distribution

  • 04961333243785 ()


  • Radiology information system
HL7 INBOUND INTERFACE (ADT/SIU/ORM)
PENTAX OF AMERICA, INC.
M70220-UP
In Commercial Distribution

  • 04961333243778 ()


  • Radiology information system
HL7 INBOUND INTERFACE (ADT/SIU/ORM)
PENTAX OF AMERICA, INC.
M70220
In Commercial Distribution

  • 04961333243761 ()


  • Radiology information system
ENDOPRO IQ REVIEW LICENSE (UNLIMITED)
PENTAX OF AMERICA, INC.
M70219-UP
In Commercial Distribution

  • 04961333243754 ()
  • 14961333243751 ()


  • Radiology information system
ENDOPRO IQ REVIEW LICENSE (UNLIMITED)
PENTAX OF AMERICA, INC.
M70219
In Commercial Distribution

  • 04961333243747 ()
  • 14961333243744 ()


  • Radiology information system
ENDOPRO IQ REVIEW LICENSE (20-30)
PENTAX OF AMERICA, INC.
M70218-UP
In Commercial Distribution

  • 04961333243730 ()
  • 14961333243737 ()


  • Radiology information system
ENDOPRO IQ REVIEW LICENSE (20-30)
PENTAX OF AMERICA, INC.
M70218
In Commercial Distribution

  • 04961333243723 ()
  • 14961333243720 ()


  • Radiology information system
ENDOPRO IQ REVIEW LICENSE (10-19)
PENTAX OF AMERICA, INC.
M70217-UP
In Commercial Distribution

  • 04961333243716 ()
  • 14961333243713 ()


  • Radiology information system
ENDOPRO IQ REVIEW LICENSE (10-19)
PENTAX OF AMERICA, INC.
M70217
In Commercial Distribution

  • 04961333243709 ()
  • 14961333243706 ()


  • Radiology information system
ENDOPRO IQ REVIEW LICENSE (1-4)
PENTAX OF AMERICA, INC.
M70216-UP
In Commercial Distribution

  • 04961333243693 ()
  • 14961333243690 ()


  • Radiology information system
ENDOPRO IQ REVIEW LICENSE (1-4)
PENTAX OF AMERICA, INC.
M70216
In Commercial Distribution

  • 04961333243686 ()
  • 14961333243683 ()


  • Radiology information system
NURSING NOTES
PENTAX OF AMERICA, INC.
M70214-UP
In Commercial Distribution

  • 04961333243679 ()


  • Radiology information system
NURSING NOTES
PENTAX OF AMERICA, INC.
M70214
In Commercial Distribution

  • 04961333243662 ()


  • Radiology information system
DOC-U-SCRIBE REPORTING
PENTAX OF AMERICA, INC.
M70213-UP
In Commercial Distribution

  • 04961333243655 ()


  • Radiology information system
DOC-U-SCRIBE REPORTING
PENTAX OF AMERICA, INC.
M70213
In Commercial Distribution

  • 04961333243648 ()


  • Radiology information system
MPS VIDEO CAPTURE
PENTAX OF AMERICA, INC.
M70212-UP
In Commercial Distribution

  • 04961333243631 ()


  • Radiology information system
MPS VIDEO CAPTURE
PENTAX OF AMERICA, INC.
M70212
In Commercial Distribution

  • 04961333243624 ()


  • Radiology information system
ENDOREMOTE
PENTAX OF AMERICA, INC.
M70211-UP
In Commercial Distribution

  • 04961333243617 ()


  • Radiology information system
ENDOREMOTE
PENTAX OF AMERICA, INC.
M70211
In Commercial Distribution

  • 04961333243600 ()


  • Radiology information system
ENDOPRO IQ (PER OR ROOM)
PENTAX OF AMERICA, INC.
M70210-UP
In Commercial Distribution

  • 04961333243594 ()


  • Radiology information system
ENDOPRO IQ (PER OR ROOM)
PENTAX OF AMERICA, INC.
M70210
In Commercial Distribution

  • 04961333243587 ()


  • Radiology information system
ENDOPRO IQ (PER MOBILE CART)
PENTAX OF AMERICA, INC.
M70209-UP
In Commercial Distribution

  • 04961333243570 ()


  • Radiology information system
ENDOPRO IQ (PER MOBILE CART)
PENTAX OF AMERICA, INC.
M70209
In Commercial Distribution

  • 04961333243563 ()


  • Radiology information system
ENDOPRO IQ AMBULATORY SITE LICENSE
PENTAX OF AMERICA, INC.
M70208-UP
In Commercial Distribution

  • 04961333243556 ()


  • Radiology information system
ENDOPRO IQ AMBULATORY SITE LICENSE
PENTAX OF AMERICA, INC.
M70208
In Commercial Distribution

  • 04961333243549 ()


  • Radiology information system
ENDOPRO IQ HOSPITAL SITE LICENSE
PENTAX OF AMERICA, INC.
M70207-UP
In Commercial Distribution

  • 04961333243532 ()


  • Radiology information system
ENDOPRO IQ HOSPITAL SITE LICENSE
PENTAX OF AMERICA, INC.
M70207
In Commercial Distribution

  • 04961333243525 ()


  • Radiology information system
ENDOPRO IQ CAPTURE LICENSE
PENTAX OF AMERICA, INC.
M70206-UP
In Commercial Distribution

  • 04961333243518 ()


  • Radiology information system
ENDOPRO IQ CAPTURE LICENSE
PENTAX OF AMERICA, INC.
M70206
In Commercial Distribution

  • 04961333243501 ()


  • Radiology information system
ENDOPRO IQ REVIEW LICENSE (5-9)
PENTAX OF AMERICA, INC.
M70205-UP
In Commercial Distribution

  • 04961333243495 ()


  • Radiology information system
ENDOPRO IQ REVIEW LICENSE (5-9)
PENTAX OF AMERICA, INC.
M70205
In Commercial Distribution

  • 04961333243488 ()


  • Radiology information system
ENDOPRO IQ CITRIX/VIRTUALIZATION LICENSE
PENTAX OF AMERICA, INC.
M70204-UP
In Commercial Distribution

  • 04961333243471 ()


  • Radiology information system
ENDOPRO IQ CITRIX/VIRTUALIZATION LICENSE
PENTAX OF AMERICA, INC.
M70204
In Commercial Distribution

  • 04961333243464 ()


  • Radiology information system
MATROX ORION HD CAPTURE CARD
PENTAX OF AMERICA, INC.
M30126
In Commercial Distribution

  • 04961333243440 ()


  • Radiology information system
MATROX VIO CAPTURE CARD
PENTAX OF AMERICA, INC.
M30119
In Commercial Distribution

  • 04961333243433 ()


  • Radiology information system
BITE BLOCK 3PCS ST
PENTAX OF AMERICA, INC.
KUMOF-Z5K
In Commercial Distribution

  • 04961333243426 ()
  • 14961333243423 ()


  • Seizure bite block
SUCTION VALVE, 2 PCS
PENTAX OF AMERICA, INC.
KUMOF-B58K
In Commercial Distribution

  • 04961333243419 ()
  • 14961333243416 ()


  • Endoscope suction valve, reusable
VALVE, SUCTION 10 PCS
PENTAX OF AMERICA, INC.
KUMOF-B53K
In Commercial Distribution

  • 04961333243402 ()
  • 14961333243409 ()


  • Endoscope suction valve, reusable
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