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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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Applications Platform 4.0 US/JPN – INT KIT – 3 Room 120087-000
IMRIS Imaging, Inc.
Application Platform 4.0 KIT
In Commercial Distribution

  • 00857534006646 ()


  • Operating room audiovisual data/device management system application software
  • Operating room audiovisual data/device management system
Applications Platform 4.0 US/JPN – INT KIT-120085-000
IMRIS Imaging, Inc.
Application Platform 4.0- KIT
In Commercial Distribution

  • 00857534006639 ()


  • Operating room audiovisual data/device management system application software
  • Operating room audiovisual data/device management system
Applications Platform 4.0 US/JPN – 3 Room- 119897-000
IMRIS Imaging, Inc.
Application Platform 4.0- 3 Room
In Commercial Distribution

  • 00857534006622 ()


  • Operating room audiovisual data/device management system application software
  • Operating room audiovisual data/device management system
Applications Platform 4.0 NA/JAPAN 2-Room- 119407-000
IMRIS Imaging, Inc.
Application Platform 4.0 2-Room
In Commercial Distribution

  • 00857534006493 ()


  • Operating room audiovisual data/device management system application software
  • Operating room audiovisual data/device management system
No Description
Brainlab AG
15800
Not in Commercial Distribution

  • 04056481140977 ()


  • Medical image management system
  • Radiology picture archiving and communication system workstation
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
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
PATRAN® dispensers, holds one box of any style PATRAN® slide sheets, 11”W x 9.5”L x 4”D, mounting hardware included. Made of PET.
Jamar Health Products, Inc.
9622 Dispenser
In Commercial Distribution

  • 00850050415176 ()
  • 00850050415169 ()


  • Patient transfer sliding mat
Wheelchair Replacement Front Caster Assembly Includes Pneumatic Casters Fork Assembly And All Hardware Fits All MediChoice 18-20 Inch Wheelchairs Not Nat Rubber Ltx Non Sterile Reusable MediChoice
OWENS & MINOR DISTRIBUTION, INC.
GEY2CA
In Commercial Distribution

  • 20885632142540 ()
  • 10885632142543 ()


  • Wheelchair wheel
The Alinity c ACE Assay File is an accessory intended to be used for driving and influencing the use of the Alinity c system automated analyser hardware.
SENTINEL CH. SPA
06U86-1A
In Commercial Distribution

  • 08058056685445 ()
06U86-1A

  • Laboratory instrument/analyser application software IVD
The ARCHITECT c ACE Assay File is an accessory intended to be used for driving and influencing the use of the ARCHITECT c systems automated analyser hardware.
SENTINEL CH. SPA
6U82-1A
In Commercial Distribution

  • 08058056685438 ()
6U82-1A

  • Laboratory instrument/analyser application software IVD
The Vios Monitoring System (VMS) Central Station Monitor (CSM) Software (SW) is indicated for use by healthcare professionals for centralized monitoring of patient data within a healthcare facility. The Vios CSM SW receives, stores, manages, and displays patient physiological and waveform data, and alarms generated by Vios proprietary patient vitals monitoring software. The Vios CSM SW is intended for clinical professionals who are expected to have a working knowledge of medical procedures, practices, and terminology, as required for monitoring patients.
MURATA VIOS, INC.
CSM2050 Software
In Commercial Distribution

  • B595CSM20500 ()
CSM2050

  • Centralized patient monitor
  • Cardiac arrhythmia monitoring system
  • Multiple vital physiological parameter monitoring system, clinical
  • Pulse oximeter
  • Clinical management support software
Wheelchair Replacement Front Caster Assembly Includes Pneumatic Casters Fork Assembly And All Hardware Fits All MediChoice 22-24 Inch Heavy Duty Wheelchairs Not Nat Rubber Ltx Non Sterile Reusable MediChoice
OWENS & MINOR DISTRIBUTION, INC.
GEY2HDCA
In Commercial Distribution

  • 20885632142557 ()
  • 10885632142550 ()


  • Wheelchair wheel
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