SEARCH RESULTS FOR: hibcc(560242 results)

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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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Audioscan Probe Tube - B161RE3670

Molded probe tube, consisting of a thin silicone tube, molded collar, and adjustable ring marker.
Etymonic Design Incorporated
RE367
In Commercial Distribution

  • B161RE3670 ()
  • B161RE3671 ()
RE367-40

  • Audiometric/hearing aid tester

Audioscan - B161AXIOM0

No Description
Etymonic Design Incorporated
Axiom
In Commercial Distribution

  • B161AXIOM3 ()
  • B161AXIOM0 ()


  • Audiometric/hearing aid tester

Clear Guide TP Access Posts - B201CGTPP0

The device is a configurable, manual surgical aid accessory with multi-modality fiducial markers and a needle guide grid for image-guided transperineal procedures. The device is intended to guide needle placements while keeping the patient's perineum accessible during endorectal ultrasound and MR/CT-guided interventions. The device is intended for use in a clinical setting. The device constitutes 3 pairs of posts (T, M, S) as a replacement for Clear Guide TP Access Tool (CG-PAT).
CLEAR GUIDE MEDICAL, INC.
CGTPP
In Commercial Distribution

  • B201CGTPP0 ()
  • B201CGTPP1 ()

  • Length: 3 Inch
  • Length: 4 Inch
  • Length: 5 Inch
CG-TPP

  • MRI-oriented needle guide positioner

Clear Guide TP Access Frame - B201CGTPF0

The device is a configurable, manual surgical aid accessory with multi-modality fiducial markers and a needle guide grid for image-guided transperineal procedures. The device is intended to guide needle placements while keeping the patient's perineum accessible during endorectal ultrasound and MR/CT-guided interventions. The device is intended for use in a clinical setting. The device is a guide frame replacement for the Clear Guide TP Access Tool (CG-PAT).
CLEAR GUIDE MEDICAL, INC.
CGTPF
In Commercial Distribution

  • B201CGTPF0 ()
  • B201CGTPF1 ()
CG-TPF

  • MRI-oriented needle guide positioner

Clear Guide SCENERGY TP - B201CGSCENERGYTP0

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

Clear Guide SCENERGY - B201CGSCENERGY0

No Description
CLEAR GUIDE MEDICAL, INC.
CGSCENERGY
In Commercial Distribution

  • B201CGSCENERGY1 ()
  • B201CGSCENERGY0 ()


  • Ultrasound imaging system application software
  • Stereotactic system application software

Clear Guide TP Access Tool - B201CGPAT0

The device is a configurable, manual surgical aid accessory with multi-modality fiducial markers and a needle guide grid for image-guided transperineal procedures. The device is intended to guide needle placements while keeping the patient's perineum accessible during endorectal ultrasound and MR/CT-guided interventions. The device is intended for use in a clinical setting.
CLEAR GUIDE MEDICAL, INC.
CGPAT
In Commercial Distribution

  • B201CGPAT0 ()
  • B201CGPAT1 ()
CG-PAT

  • MRI-oriented needle guide positioner
  • Patient positioner base plate

Clear Guide ONE - B201CGONE0

No Description
CLEAR GUIDE MEDICAL, INC.
CGONE
In Commercial Distribution

  • B201CGONE1 ()
  • B201CGONE0 ()


  • Ultrasound imaging system application software

Clear Guide Optical Head - B201CGOHM0

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

Clear Guide Optical Head - B201CGOH0

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
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