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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Balloon Catheter
MICROVENTION INC.
BC0410C-B
In Commercial Distribution

  • 00810170018534 ()

  • 4.0 mm x 10 mm
BC0410C

  • Intravascular occluding balloon catheter, image-guided
Balloon Catheter
MICROVENTION INC.
BC0411XC
In Commercial Distribution

  • 00810170016370 ()

  • 4.0 mm x 11 mm
BC0411XC

  • Intravascular occluding balloon catheter, image-guided
Balloon Catheter
MICROVENTION INC.
BC0420C
In Commercial Distribution

  • 00810170015823 ()

  • 4.0 mm x 20 mm
BC0420C

  • Intravascular occluding balloon catheter, image-guided
Balloon Catheter
MICROVENTION INC.
BC0415C
In Commercial Distribution

  • 00810170015816 ()

  • 4.0 mm x 15 mm
BC0415C

  • Intravascular occluding balloon catheter, image-guided
Balloon Catheter
MICROVENTION INC.
BC0410C
In Commercial Distribution

  • 00810170015809 ()

  • 4.0 mm x 10 mm
BC0410C

  • Intravascular occluding balloon catheter, image-guided
Steering Cloth Electrode, Left
BIONESS INC.
SCE-1100
In Commercial Distribution

  • 00815962020436 ()


  • Transcutaneous electrical stimulation electrode, reusable
Steering Cloth Electrode, Right
BIONESS INC.
SCE-1000
In Commercial Distribution

  • 00815962020429 ()


  • Transcutaneous electrical stimulation electrode, reusable
The Clear Guide SCENERGY is software that provides fusion of images from Computed Tomography (CT), Magnetic Resonance (MR), and Ultrasound (US) modalities. US images can be fused with either CT or MR. The Clear Guide SCENERGY utilizes the Clear Guide CORE and Clear Guide Optical Head platform to display images of the target regions and the projected path of the interventional instrument, while taking into account patient movement and deformation. Instrumentation used with the Clear Guide SCENERGY might include an interventional needle or needle-like rigid device, such as a biopsy needle, an aspiration needle, or an ablation needle. The device is intended to be used in any interventional or diagnostic procedure where the combination of these modalities is used for visualization, except for procedures on the brain. The device is intended for use in a clinical setting, in patients of sufficient size (at least 25 kg).
CLEAR GUIDE MEDICAL, INC.
CGSCENERGYTP
In Commercial Distribution

  • B201CGSCENERGYTP0 ()
  • B201CGSCENERGYTP1 ()
CG-SCENERGY-TP

  • Surgical planning/navigation-enhancement system
  • Stereotactic system application software
No Description
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
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