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-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
Screw, Cortical, Poly Cann, 4.75 x 30mm
Kalitec Direct LLC
10-SNP-4730
In Commercial Distribution

  • B07310SNP47301 ()
10-SNP-4730

  • Spinal bone screw, non-bioabsorbable
Emergency Screw - Ø1.4 mm x 12 mm [5 PK]
Bioplate, Inc.
SCE8-12-05
In Commercial Distribution

  • M384SCE812051 ()
  • M384SCE812050 ()

  • Length: 12 Millimeter
SCE8-12-05

  • Craniofacial bone screw, non-bioabsorbable
Emergency Screw - Ø1.4 mm x 12 mm
Bioplate, Inc.
SCE8-12-01
In Commercial Distribution

  • M384SCE812010 ()

  • Length: 12 Millimeter
SCE8-12-01

  • Craniofacial bone screw, non-bioabsorbable
Emergency Screw - Ø1.4 mm x 10 mm [5 PK]
Bioplate, Inc.
SCE8-10-05
In Commercial Distribution

  • M384SCE810051 ()
  • M384SCE810050 ()

  • Length: 10 Millimeter
SCE8-10-05

  • Craniofacial bone screw, non-bioabsorbable
Emergency Screw - Ø1.4 mm x 10 mm
Bioplate, Inc.
SCE8-10-01
In Commercial Distribution

  • M384SCE810010 ()

  • Length: 10 Millimeter
SCE8-10-01

  • Craniofacial bone screw, non-bioabsorbable
Emergency Screw - Ø1.4 mm x 8 mm [5 PK]
Bioplate, Inc.
SCE8-08-05
In Commercial Distribution

  • M384SCE808051 ()
  • M384SCE808050 ()

  • Length: 8 Millimeter
SCE8-08-05

  • Craniofacial bone screw, non-bioabsorbable
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