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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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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
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
ONEFIT MEDICAL
KIT0708
Not in Commercial Distribution

  • 03700757200803 ()
/

  • 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
KIT0707
Not in Commercial Distribution

  • 03700757200797 ()
/

  • 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
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
KIT0704
Not in Commercial Distribution

  • 03700757200766 ()
/

  • 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
KIT0703
Not in Commercial Distribution

  • 03700757200759 ()
/

  • 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
AccuTab is a tablet with associated software (AccuData) that connects to the Accuryn Monitor. The tablet is an extension of the Accuryn Monitor and only displays the data that already exists on the Accuryn Monitor. AccuTab with AccuData is solely intended to transfer, store, convert forms, and display medical device data from the Accuryn Monitor.
POTRERO MEDICAL, INC.
FGN-06-101581
In Commercial Distribution

  • 00850019755015 ()
FGN-06-101581

  • Multi-parameter urinary monitoring system control unit
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