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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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A physical template / guide that is positioned on patients’ anatomy (Bony and / or Occulsal), and allows for precise location of predetermined osteotomy planes and holes
3D SYSTEMS, INC.
LeFort Marking Guide with Predictive Hole Placement
In Commercial Distribution

  • 00816847020602 ()


  • Custom-made orthopaedic/craniofacial surgical guide
A physical template / guide that is positioned on patients’ anatomy (Bony and / or Occulsal), and allows for precise location of predetermined osteotomy planes and holes
3D SYSTEMS, INC.
LeFort Marking Guide
In Commercial Distribution

  • 00816847020596 ()


  • Custom-made orthopaedic/craniofacial surgical guide
A physical template / guide that conforms to patients’ anatomy (Bony and / or Occlusal) to allow manipulation of free floating bony anatomy.
3D SYSTEMS, INC.
LeFort Positioning Guide
In Commercial Distribution

  • 00816847020589 ()


  • Custom-made orthopaedic/craniofacial surgical guide
A physical template / guide that is positioned on patients’ anatomy (Bony and / or Occulsal), and allows for precise location of predetermined osteotomy planes and holes
3D SYSTEMS, INC.
LeFort Drilling Guide
In Commercial Distribution

  • 00816847020572 ()


  • Custom-made orthopaedic/craniofacial surgical guide
A physical template / guide that conforms to patients’ anatomy (Bony and / or Occlusal) to allow manipulation of free floating bony anatomy.
3D SYSTEMS, INC.
Final Palatal Splint (No Dentition Included)
In Commercial Distribution

  • 00816847020565 ()


  • Custom-made orthopaedic/craniofacial surgical guide
A physical template / guide that conforms to patients’ anatomy (Bony and / or Occlusal) to allow manipulation of free floating bony anatomy.
3D SYSTEMS, INC.
Intermediate Sandwich Surgical Splint
In Commercial Distribution

  • 00816847020558 ()


  • Custom-made orthopaedic/craniofacial surgical guide
A physical template / guide that conforms to patients’ anatomy (Bony and / or Occlusal) to allow manipulation of free floating bony anatomy.
3D SYSTEMS, INC.
Final Surgical Splint
In Commercial Distribution

  • 00816847020541 ()


  • Custom-made orthopaedic/craniofacial surgical guide
A physical template / guide that conforms to patients’ anatomy (Bony and / or Occlusal) to allow manipulation of free floating bony anatomy.
3D SYSTEMS, INC.
Intermediate Surgical Splint
In Commercial Distribution

  • 00816847020534 ()


  • Custom-made orthopaedic/craniofacial surgical guide
A physical template / guide that conforms to patients’ anatomy (Bony and / or Occlusal) to allow manipulation of free floating bony anatomy.
3D SYSTEMS, INC.
Initial Surgical Splint
In Commercial Distribution

  • 00816847020527 ()


  • Custom-made orthopaedic/craniofacial surgical guide
A physical template / guide that conforms to patients’ anatomy (Bony and / or Occlusal) to allow manipulation of free floating bony anatomy.
3D SYSTEMS, INC.
Surgical Splint
In Commercial Distribution

  • 00816847020510 ()


  • Custom-made orthopaedic/craniofacial surgical guide
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