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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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Black Tamper Evident Luer Lock Caps for IV Syringes. Sterile, Tray of 10, box of 1000. Provides Evidence of Access and maintains sterility
INTERNATIONAL MEDICAL INDUSTRIES INC.
17360K
In Commercial Distribution

  • B21217360K2 ()
  • B21217360K1 ()
  • B21217360K0 ()
17360K

  • Syringe tip cap
Blue Tamper Evident Luer Lock Caps for IV Syringes. Sterile, Tray of 10, box of 1000. Provides Evidence of Access and maintains sterility
INTERNATIONAL MEDICAL INDUSTRIES INC.
17360BC
In Commercial Distribution

  • B21217360BC2 ()
  • B21217360BC1 ()
  • B21217360BC0 ()
17360BC

  • Syringe tip cap
Blue Tamper Evident Luer Lock Caps for IV Syringes. Sterile, Tray of 10, box of 1000. Provides Evidence of Access and maintains sterility
INTERNATIONAL MEDICAL INDUSTRIES INC.
17360B
In Commercial Distribution

  • B21217360B2 ()
  • B21217360B1 ()
  • B21217360B0 ()
17360B

  • Syringe tip cap
Oral Tamper Evident Cap for Baxter / ExactaMed Oral Dispenser. Non-Sterile, Bag of 100, Box of 1000. Provides Evidence of Access and Positive Closure
INTERNATIONAL MEDICAL INDUSTRIES INC.
17286
In Commercial Distribution

  • B212172862 ()
  • B212172861 ()
  • B212172860 ()
17286

  • Oral liquid dose dispenser cabinet
The device is a sterile accessory intended to provide a sterile barrier for medical procedures that require sterility and utilize the Clear Guide SuperPROBE (customer's ultrasound probe with Clear Guide Optical Head). The device is intended to be used in clinical settings, by clinicians familiar with aseptic technique.
CLEAR GUIDE MEDICAL, INC.
CGSM
In Commercial Distribution

  • B201CGSM1 ()
  • B201CGSM0 ()


  • Intraoperative ultrasound imaging transducer cover
  • Optical medical device procedural cover
No Description
CLEAR GUIDE MEDICAL, INC.
CGSCENERGY
In Commercial Distribution

  • B201CGSCENERGY1 ()
  • B201CGSCENERGY0 ()


  • Ultrasound imaging system application software
  • Stereotactic system application software
No Description
CLEAR GUIDE MEDICAL, INC.
CGONE
In Commercial Distribution

  • B201CGONE1 ()
  • B201CGONE0 ()


  • Ultrasound imaging system application software
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
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
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