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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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An electrically-powered computer-aided image-guided stereotactic system that typically consist of a mobile cart or carts, computer, 3D tracking system, surgical instruments that can be tracked, and application software for treatment planning and intraoperative navigation in cranial, ENT, and spine surgical procedures. Intraoperative navigation relies on individual or fused CT and MRI scans registered to the patient to allow the surgeon to correlate the position of navigated instruments used in surgery to the 3D images in real-time.
MED-SURGICAL SERVICES, INC.
90000
In Commercial Distribution

  • 00860008782700 ()


  • Multi-purpose stereotactic surgery system
Patient-specific, partial-face 3D printed anatomic model depicting a patient’s treatment plan. Non-diagnostic. RX only
Mirrorme3d, LLC
MNMS
In Commercial Distribution

  • 00860008704184 ()


  • Custom-made organ/bone anatomy model
Patient-specific, partial face 3D printed anatomic model depicting a patient’s baseline or preoperative status. Non-diagnostic. Rx only.
Mirrorme3d, LLC
MNMB
In Commercial Distribution

  • 00860008704177 ()


  • Custom-made organ/bone anatomy model
Patient-specific, partial-face 3D printed anatomic model depicting a patient’s treatment plan. Non-diagnostic. RX only.
Mirrorme3d, LLC
MRCS
In Commercial Distribution

  • 00860008704160 ()


  • Custom-made organ/bone anatomy model
Patient-specific, partial face 3D printed anatomic model depicting a patient’s baseline or preoperative status. Non-diagnostic. Rx only.
Mirrorme3d, LLC
MRCB
In Commercial Distribution

  • 00860008704153 ()


  • Custom-made organ/bone anatomy model
Patient-specific, full-face 3D printed anatomic model depicting a patient’s treatment plan. Non-diagnostic. RX only.
Mirrorme3d, LLC
FFS
In Commercial Distribution

  • 00860008704146 ()


  • Custom-made organ/bone anatomy model
Patient-specific, full-face 3D printed anatomic model depicting a patient’s baseline or preoperative status. Non-diagnostic. Rx only.
Mirrorme3d, LLC
FFB
In Commercial Distribution

  • 00860008704139 ()


  • Custom-made organ/bone anatomy model
OxiWear Device and Charger Bundle - Medical - Package of 1
OXIWEAR, INC.
OxiV3
In Commercial Distribution

  • 00860008683236 ()
  • 10860008683233 ()
  • 20860008683230 ()
M-001-01

  • Wearable multiple physiological parameter recorder, reusable
Endovaginal Probe 3D
Halo Medical Technologies, LLC
HMT-EVG 3D
In Commercial Distribution

  • 00860008657374 ()


  • Rectal/vaginal ultrasound imaging transducer
Endovaginal Probe 2D
Halo Medical Technologies, LLC
HMT-EVG
In Commercial Distribution

  • 00860008657367 ()


  • Rectal/vaginal ultrasound imaging transducer
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