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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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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
Rescuer Emergency CPAP Systems with small CPAP mask and pre-attached bonnet is a single patient use disposable CPAP generator to be used on patients exhibiting acute respiratory distress.
B.L.S. Systems Limited
8710
In Commercial Distribution

  • B20087101 ()
  • B20087100 ()

  • Small CPAP Mask
8710

  • CPAP/BPAP face mask, single-use
B200 SERIES PULSE OXIMETER SENSOR
BETA BIOMED SERVICES INC
B200-1016
In Commercial Distribution

  • B200101603 ()
  • B2001016 ()


  • Pulse oximeter, line-powered
B200 SERIES PULSE OXIMETER SENSOR
BETA BIOMED SERVICES INC
B200-1011M
In Commercial Distribution

  • B2001011M03 ()
  • B2001011M01 ()


  • Pulse oximeter, line-powered
B200 SERIES PULSE OXIMETER
BETA BIOMED SERVICES INC
B200-1004N
In Commercial Distribution

  • B2001004N03 ()
  • B2001004N01 ()


  • Pulse oximeter, line-powered
sterile bags
BONE FOAM, INC.
925.TRSB
Not in Commercial Distribution

  • B197925TRSB1 ()
  • B197925TRSB0 ()
925.TRSB

  • Medical equipment/instrument drape, single-use
sterile bags
BONE FOAM, INC.
925.TRPPSB
Not in Commercial Distribution

  • B197925TRPPSB1 ()
  • B197925TRPPSB0 ()
925.TRPPSB

  • Medical equipment/instrument drape, single-use
sterile bags
BONE FOAM, INC.
925.SCTRSB
Not in Commercial Distribution

  • B197925SCTRSB1 ()
  • B197925SCTRSB0 ()
925.SCTRSB

  • Medical equipment/instrument drape, single-use
sterile bags
BONE FOAM, INC.
925.SBCB
Not in Commercial Distribution

  • B197925SBCB1 ()
  • B197925SBCB0 ()
925.SBCB

  • Medical equipment/instrument drape, single-use
sterile bags
BONE FOAM, INC.
925.PTRSB
Not in Commercial Distribution

  • B197925PTRSB1 ()
  • B197925PTRSB0 ()
925.PTRSB

  • Medical equipment/instrument drape, single-use
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