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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CLEAR GUIDE MEDICAL, INC.
CGSCENERGY
In Commercial Distribution

  • B201CGSCENERGY1 ()
  • B201CGSCENERGY0 ()


  • Ultrasound imaging system application software
  • Stereotactic system application software
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-CORE24-MR model is a modified version of CG-CORE24 with significantly reduced ferromagnetic components internally.
CLEAR GUIDE MEDICAL, INC.
CGCORE24MR
In Commercial Distribution

  • B201CGCORE24MR0 ()
  • B201CGCORE24MR1 ()
CG-CORE24-MR

  • Stereotactic surgery system workstation
  • Ultrasound imaging system workstation
  • Optical surgical navigation device tracking system workstation, mobile
  • Panel computer
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-CORE24 model is a panel PC with a 24" screen.
CLEAR GUIDE MEDICAL, INC.
CGCORE24
In Commercial Distribution

  • B201CGCORE240 ()
  • B201CGCORE241 ()
CG-CORE24

  • Ultrasound imaging system workstation
  • Stereotactic surgery system workstation
  • Optical surgical navigation device tracking system workstation, mobile
  • Panel computer
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-CORE17 model is a panel PC with a 17" screen.
CLEAR GUIDE MEDICAL, INC.
CGCORE17
In Commercial Distribution

  • B201CGCORE170 ()
  • B201CGCORE171 ()
CG-CORE17

  • Ultrasound imaging system workstation
  • Optical surgical navigation device tracking system workstation, mobile
  • Panel computer
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
Enzymatic Formula with Rust Inhibitor, 1 Gallon Bottle, Citrus Scent
CROSSTEX INTERNATIONAL, INC.
JEZ
In Commercial Distribution

  • 50732224016462 ()
  • 10732224016464 ()
JEZ

  • Medical device disinfection agent
White/Pink, Bubblegum Scented
CROSSTEX INTERNATIONAL, INC.
M1005WHPK
In Commercial Distribution

  • 50732224005022 ()
  • 10732224005024 ()
  • 00732224005027 ()
M1005WHPK

  • Dental suction system cannula, single-use
White/Green, Mint Scented
CROSSTEX INTERNATIONAL, INC.
M1004WHGR
In Commercial Distribution

  • 50732224005015 ()
  • 10732224005017 ()
  • 00732224005010 ()
M1004WHGR

  • Dental suction system cannula, single-use
Ultrasonic Acidic Detergent,1 Gallon Bottle, Clear Color, Sweet Scent
CROSSTEX INTERNATIONAL, INC.
JEZTS
In Commercial Distribution

  • 50732224002380 ()
  • 10732224002382 ()
JEZTS

  • Medical device disinfection agent
Comfort Plus™ Premium Saliva Ejectors, White,Green, Mint Scented
CROSSTEX INTERNATIONAL, INC.
ZWGCPM
In Commercial Distribution

  • 50732224000843 ()
  • 10732224000845 ()
  • 00732224000848 ()


  • Dental suction system cannula, single-use
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