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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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SpecialsLab - 00840682123587

SOFTWARE SPECIALSLAB V6.9.6 R3
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
v6.9.6 R3
Not in Commercial Distribution

  • 00840682123587 ()


  • Cardiac catheterization monitoring system
  • Cardiac electrophysiology analysis system

ComboLab - 00840682123570

SOFTWARE COMBOLAB V6.9.6 R3
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
v6.9.6 R3
In Commercial Distribution

  • 00840682123570 ()


  • Cardiac catheterization monitoring system
  • Cardiac electrophysiology analysis system

Mac-Lab - 00840682123556

SOFTWARE MAC-LAB V6.9.6 R3
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
v6.9.6 R3
In Commercial Distribution

  • 00840682123556 ()


  • Cardiac catheterization monitoring system
  • Cardiac electrophysiology analysis system

CardioLab - 00840682123549

SOFTWARE CARDIOLAB V6.9.6 R3
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
v6.9.6 R3
In Commercial Distribution

  • 00840682123549 ()


  • Cardiac catheterization monitoring system
  • Cardiac electrophysiology analysis system

KBA3D - 03701313000479

Spinal surgery planning software
S.M.A.I.O
V1.1.X
Not in Commercial Distribution

  • 03701313000479 ()


  • Radiological PACS software

KBA3D - 03701313007935

Spinal surgery planning software
S.M.A.I.O
V2.0.0
In Commercial Distribution

  • 03701313007935 ()


  • Radiological PACS software

coDiagnostiX - D835CDX1

Dental implant planning software
Dental Wings GmbH
9
Not in Commercial Distribution

  • D835CDX202 ()
  • D835CDX1 ()
  • D835CDX201 ()
  • D835CDX200 ()


  • Diagnostic x-ray digital imaging system workstation

Smart Correction - B562C2C20210

Click2Correct/ Smart Correction software
Wishbone Medical, Inc.
C2C20210
Not in Commercial Distribution

  • B562C2C20210 ()


  • External orthopaedic fixation frame calculation software

Messenger - 00086001142550

Messenger 6.0.0 Software Release
SPOK INC.
6.0.0
In Commercial Distribution

  • 00086001142550 ()


  • Alarm application software

DOSE IQ SAFETY SOFTWARE - 00085412676616

Infusion Safety Management Software
BAXTER HEALTHCARE CORPORATION
DOSEIQW0001
In Commercial Distribution

  • 00085412676616 ()
DOSEIQW0001

  • Infusion pump medication-dosage application software
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