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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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Mallet
ARTHREX, INC.
AR-S4100-100-000
In Commercial Distribution

  • 00888867426979 ()
AR-S4100-100-000

  • Surgical mallet
No Description
Modern Surgical Instruments LLC
17-4623
In Commercial Distribution

  • B4191746230 ()


  • Surgical screwdriver, reusable
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.
Fibula Cutting Guide
In Commercial Distribution

  • 00816847020794 ()


  • 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.
Fibula Marking Guide with Implant Placement
In Commercial Distribution

  • 00816847020787 ()


  • 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.
Fibula Cutting Guide with Implant Placement
In Commercial Distribution

  • 00816847020770 ()


  • 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 Positioning Guide
In Commercial Distribution

  • 00816847020763 ()


  • 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 Positioning Template
In Commercial Distribution

  • 00816847020756 ()


  • Custom-made orthopaedic/craniofacial surgical guide
A physical guide used to hold bone in a position dictated by the surgeon for a limited amount of time. Once the bone repositioning guide stabilizes the position of the patient’s bone; the surgeon can determine a permanent solution
3D SYSTEMS, INC.
Bone Repositioning Guide
In Commercial Distribution

  • 00816847020749 ()


  • 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.
Maxillofacial Positioning Guide
In Commercial Distribution

  • 00816847020732 ()


  • 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.
Bone Positioning Wedge
In Commercial Distribution

  • 00816847020725 ()


  • Custom-made orthopaedic/craniofacial surgical guide
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