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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The device is intended as a computer platform to perform computation, display, connectivity and user input functions for CLEAR GUIDE image guidance software (e.g., Clear Guide SCENERGY). The device facilitates rigid, needle-like surgical instrument tracking and guidance feedback for diagnostic and interventional procedures in a clinical setting. The CG-CORE13 model is a tablet PC with a 13" screen.
CLEAR GUIDE MEDICAL, INC.
CGCORE13
In Commercial Distribution

  • B201CGCORE130 ()
  • B201CGCORE131 ()
CG-CORE-13

  • Ultrasound imaging system workstation
  • Stereotactic surgery system workstation
  • Optical surgical navigation device tracking system workstation, mobile
  • Portable computer
Oxygen Concentrator, 1-5 LPM
CAIRE INC.
SCE1000-NANB
In Commercial Distribution

  • M766SCE1000NANB0 ()
SCE1000-NANB

  • Stationary oxygen concentrator
The Maritime First Aid Family of Kits provide users with Advanced Medical products for use in medical trauma scenarios.
Safeguard US Operating, LLC
01
In Commercial Distribution

  • M6898142003010 ()
81-420-03

  • First aid kit, non-medicated, single-use
The Maritime First Aid Family of Kits provide users with Advanced Medical products for use in medical trauma scenarios.
Safeguard US Operating, LLC
01
In Commercial Distribution

  • M6898143003010 ()
81-430-03

  • First aid kit, non-medicated, single-use
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