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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This is a 3D face scanner that works with the supplied software programs. By performing facial scanning directly, the scanner could acquire and save the 3D images of the face and the jaw movement tracking data, which can be used for the facial or the oral Computer-aided design (CAD).
Shining 3D Tech Co., Ltd.
MetiSmile
In Commercial Distribution

  • 06970163081489 ()


  • Jaw physiology evaluation system
This is a 3D face scanner that works with the supplied software programs. By performing facial scanning directly, the scanner could acquire and save the 3D images of the face and the jaw movement tracking data, which can be used for the facial or the oral Computer-aided design (CAD).
Shining 3D Tech Co., Ltd.
MetiSmile
In Commercial Distribution

  • 06970163081229 ()


  • Jaw physiology evaluation system
This is a 3D face scanner that works with the supplied software programs. By performing facial scanning directly, the scanner could acquire and save the 3D images of the face and the jaw movement tracking data, which can be used for the facial or the oral Computer-aided design (CAD).
Shining 3D Tech Co., Ltd.
MetiSmile
In Commercial Distribution

  • 06970163080192 ()


  • Jaw physiology evaluation system
The VisionAir 3D Stent (Patient-Specific Silicone Airway Stent) is comprised of a cloud-based software suite and the patient-specific airway stent. These two function together as a system to treat symptomatic stenosis of the airway per the indications for use. The implantable patient-specific airway stent is designed by a physician using a CT scan as a guide in the cloud-based software suite. The airway is segmented from the CT scan and used by the physician in designing a patient-specific stent. When design is complete, the stent is manufactured via silicone injection into a 3D-printed mold and delivered to the treating physician non-sterile, to be sterilized before use.
VisionAir Solutions, LLC
1
In Commercial Distribution

0010-0126

  • Polymeric tracheal/bronchial stent, non-bioabsorbable
spineEOS rod template is intended to be designed from patient’s imaging data (EOS images) in order to obtain a patient specific template, which allows to reproduce the shape of the planned spinal rods during surgery. Preoperative planning is performed and validated by surgeon with spineEOS software (provide a preoperative planning solution for spine surgeries). The template is designed from the output data of the software. This device is intended for guiding the surgeon during the bending of rods for spinal arthrodesis. However, in this context, the surgeon is the only one to determine whether patients can benefit from this technology according to his habits and his surgical experience.
ONEFIT MEDICAL
KIT0706
Not in Commercial Distribution

  • 03700757200780 ()
/

  • Surgical implant template, single-use
spineEOS rod template is intended to be designed from patient’s imaging data (EOS images) in order to obtain a patient specific template, which allows to reproduce the shape of the planned spinal rods during surgery. Preoperative planning is performed and validated by surgeon with spineEOS software (provide a preoperative planning solution for spine surgeries). The template is designed from the output data of the software. This device is intended for guiding the surgeon during the bending of rods for spinal arthrodesis. However, in this context, the surgeon is the only one to determine whether patients can benefit from this technology according to his habits and his surgical experience.
ONEFIT MEDICAL
KIT0705
Not in Commercial Distribution

  • 03700757200773 ()
/

  • Surgical implant template, single-use
spineEOS rod template is intended to be designed from patient’s imaging data (EOS images) in order to obtain a patient specific template, which allows to reproduce the shape of the planned spinal rods during surgery. Preoperative planning is performed and validated by surgeon with spineEOS software (provide a preoperative planning solution for spine surgeries). The template is designed from the output data of the software. This device is intended for guiding the surgeon during the bending of rods for spinal arthrodesis. However, in this context, the surgeon is the only one to determine whether patients can benefit from this technology according to his habits and his surgical experience.
ONEFIT MEDICAL
KIT0702
Not in Commercial Distribution

  • 03700757200650 ()
/

  • Surgical implant template, single-use
spineEOS rod template is intended to be designed from patient’s imaging data (EOS images) in order to obtain a patient specific template, which allows to reproduce the shape of the planned spinal rods during surgery. Preoperative planning is performed and validated by surgeon with spineEOS software (provide a preoperative planning solution for spine surgeries). The template is designed from the output data of the software. This device is intended for guiding the surgeon during the bending of rods for spinal arthrodesis. However, in this context, the surgeon is the only one to determine whether patients can benefit from this technology according to his habits and his surgical experience.
ONEFIT MEDICAL
KIT0701
Not in Commercial Distribution

  • 03700757200643 ()
/

  • Surgical implant template, single-use
GAMMAPRO is a wireless ionizing radiation detector probe for use in the medical environment. The instrument is optimized to detect a determined range of gamma radiation energies and maximizes sensitivity and directivity. GAMMAPRO is comprised of the probe and the software installed in a control unit that is compatible with its use. GAMMAPRO is presented in 4 models: normal (GAMMAPRO STD), High Sensitivity (GAMMAPRO Hi-S), laparoscopic (GAMMAPRO LAP model) and ANGLED (GAMMAPRO ANG).
GENERAL EQUIPMENT FOR MEDICAL IMAGING SA
ANGLED
In Commercial Distribution

  • 08437018413294 ()

  • Length: 259 Millimeter
  • Weight: 122 Gram
  • Width: 40 Millimeter
  • Height: 40 Millimeter
IC-1180

  • Intraoperative gamma radiation detection system probe, reusable
GAMMAPRO is a wireless ionizing radiation detector probe for use in the medical environment. The instrument is optimized to detect a determined range of gamma radiation energies and maximizes sensitivity and directivity. GAMMAPRO is comprised of the probe and the software installed in a control unit that is compatible with its use. GAMMAPRO is presented in 4 models: normal (GAMMAPRO STD), High Sensitivity (GAMMAPRO Hi-S), laparoscopic (GAMMAPRO LAP model) and ANGLED (GAMMAPRO ANG).
GENERAL EQUIPMENT FOR MEDICAL IMAGING SA
HI-S
In Commercial Distribution

  • 08437018413096 ()

  • Height: 40 Millimeter
  • Length: 255 Millimeter
  • Weight: 182 Gram
  • Width: 40 Millimeter
IC-1160

  • Intraoperative gamma radiation detection system probe, reusable
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