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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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E-Scribe ECG Data Management Workstation - Rx system, floating; English system language; 220V power; Tower workstation computer hardware (no keyboard, mouse, or display); 19 in. display monitor
WELCH ALLYN, INC.
901134
In Commercial Distribution

  • 00732094264999 ()
ESWKST-FAB-AAXXX

  • Patient health record information system application software
E-Scribe ECG Data Management Workstation - Enterprise system, floating; English system language; 110V power; Tower workstation computer hardware (no keyboard, mouse, or display); 24 in. widescreen display monitor
WELCH ALLYN, INC.
901134
In Commercial Distribution

  • 00732094265064 ()
ESWKST-DAA-ABXXX

  • Patient health record information system application software
The device is intended as an accessory hardware to provide input into medical device software by capturing video and other sensory information from the operational field for purposes of future processing. The device facilitates rigid, needle-like surgical instrument tracking and guidance feedback for diagnostic and interventional procedures in a clinical setting.
CLEAR GUIDE MEDICAL, INC.
CGOHM
In Commercial Distribution

  • B201CGOHM0 ()
  • B201CGOHM1 ()
CG-OH-M

  • Radiological video camera patient positioning/tracking system camera
  • Optical surgical navigation device tracking system
The device is intended as an accessory hardware to provide input into medical device software by capturing video and other sensory information from the operational field for purposes of future processing. The device facilitates rigid, needle-like surgical instrument tracking and guidance feedback for diagnostic and interventional procedures in a clinical setting.
CLEAR GUIDE MEDICAL, INC.
CGOH
In Commercial Distribution

  • B201CGOH1 ()
  • B201CGOH0 ()
CG-OH

  • Radiological video camera patient positioning/tracking system camera
  • Optical surgical navigation device tracking system
BONE SCREW, EDX - 3.2Ø x 16mm
XNAV TECHNOLOGIES LLC
P010308
In Commercial Distribution

  • 00817421021442 ()
  • 00817421021435 ()
  • 00817421022739 ()
P010308

  • Surgical planning/navigation-enhancement system
  • Craniofacial bone screw, non-bioabsorbable
BONE SCREW, EDX - 3.2Ø x 8mm
XNAV TECHNOLOGIES LLC
P010307
In Commercial Distribution

  • 00817421021428 ()
  • 00817421021411 ()
  • 00817421022722 ()
P010307

  • Surgical planning/navigation-enhancement system
  • Craniofacial bone screw, non-bioabsorbable
BONE SCREW, EDX - 3.2Ø x 4mm
XNAV TECHNOLOGIES LLC
P010306
In Commercial Distribution

  • 00817421021404 ()
  • 00817421021398 ()
  • 00817421022715 ()
P010306

  • Surgical planning/navigation-enhancement system
  • Craniofacial bone screw, non-bioabsorbable
BONE SCREW, EDX - 2.7Ø x 16mm
XNAV TECHNOLOGIES LLC
P010305
In Commercial Distribution

  • 00817421021381 ()
  • 00817421021374 ()
  • 00817421022708 ()
P010305

  • Surgical planning/navigation-enhancement system
  • Craniofacial bone screw, non-bioabsorbable
BONE SCREW, EDX - 2.7Ø x 8mm
XNAV TECHNOLOGIES LLC
P010304
In Commercial Distribution

  • 00817421021367 ()
  • 00817421021350 ()
  • 00817421022692 ()
P010304

  • Surgical planning/navigation-enhancement system
  • Craniofacial bone screw, non-bioabsorbable
BONE SCREW, EDX - 2.7Ø x 4mm
XNAV TECHNOLOGIES LLC
P010303
In Commercial Distribution

  • 00817421021343 ()
  • 00817421021336 ()
  • 00817421022685 ()
P010303

  • Surgical planning/navigation-enhancement system
  • Craniofacial bone screw, non-bioabsorbable
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