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.
Distractor Marking Guide
In Commercial Distribution

  • 00816847020701 ()


  • 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.
Trauma Positioning Guide
In Commercial Distribution

  • 00816847020695 ()


  • 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.
Trauma Drilling Guide
In Commercial Distribution

  • 00816847020688 ()


  • 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.
Genioplasty Marking Guide
In Commercial Distribution

  • 00816847020671 ()


  • 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.
Genioplasty Positioning Guide
In Commercial Distribution

  • 00816847020664 ()


  • 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.
Genioplasty Drilling Guide
In Commercial Distribution

  • 00816847020657 ()


  • 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.
Sagittal Split Marking Guide with Predictive Hole Placement
In Commercial Distribution

  • 00816847020640 ()


  • 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.
Sagittal Split Marking Guide
In Commercial Distribution

  • 00816847020633 ()


  • 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.
Proximal Segment Positioning Guide
In Commercial Distribution

  • 00816847020626 ()


  • 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.
Proximal Segment Drilling Guide
In Commercial Distribution

  • 00816847020619 ()


  • 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 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
DRIVER, HEADED PIN EPIK
Encore Medical, L.P.
800-03-028
In Commercial Distribution

  • 00888912126250 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
Canes & CrutchesAccessories Product Description: Bling Cane Strap, Teal, 1/EA, 12/BX
Drive Devilbiss Healthcare
RTL10377TL
Not in Commercial Distribution

  • 10822383903696 ()
  • 00822383903699 ()
  • 50822383903694 ()


  • Walking aid tip
Canes & CrutchesAccessories Product Description: Flex N Go Cane Tip Tool Free
Drive Devilbiss Healthcare
RTL10352TF
Not in Commercial Distribution

  • 50822383576737 ()
  • 00822383576732 ()


  • Walking aid tip
Ø3.2mm x 195mm Drill for HA Half Pins (SF1324)
Paragon 28, Inc.
P45-960-3219-S
In Commercial Distribution

  • 00889795117960 ()
P45-960-3219-S

  • Cannulated surgical drill bit, single-use
Hex Driver on T Handle
Paragon 28, Inc.
P45-515-0001
In Commercial Distribution

  • 00889795116482 ()
P45-515-0001

  • Surgical screwdriver, reusable
T-wrench/pin driver
Paragon 28, Inc.
P47-940-0001
In Commercial Distribution

  • 00889795114914 ()
P47-940-0001

  • Surgical instrument handle, non-torque-limiting
Cannulated Drill, ø4.5mm x 10cm, Sterile
Paragon 28, Inc.
P44-941-4310-S
In Commercial Distribution

  • 00889795114372 ()
P44-941-4310-S

  • Cannulated surgical drill bit, single-use
Cannulated Drill, ø3.5mm x 10cm, Sterile
Paragon 28, Inc.
P44-941-3510-S
In Commercial Distribution

  • 00889795114365 ()
P44-941-3510-S

  • Cannulated surgical drill bit, single-use
R3ACT Removal Driver
Paragon 28, Inc.
P80-940-3904
In Commercial Distribution

  • 00889795113757 ()
P80-940-3904

  • Surgical screwdriver, reusable
HEX SCREW DRIVER, SHORT, 3.5mm X 155mm
Paragon 28, Inc.
P99-150-HX35-SHORT
In Commercial Distribution

  • 00889795110961 ()
P99-150-HX35-SHORT

  • Surgical screwdriver, reusable
PALM Ratcheting Driver Handle w/ AO Connect w/ Suture Cleat
Paragon 28, Inc.
P99-000-AORP
In Commercial Distribution

  • 00889795107589 ()
P99-000-AORP

  • Surgical instrument handle, non-torque-limiting
Blind Tunnel Driver Handle w/ AO Connect w/ Suture Cleat
Paragon 28, Inc.
P41-980-1000
In Commercial Distribution

  • 00889795107572 ()
P41-980-1000

  • Suturing unit, single-use
Ø7.0/8.0 Driver Sleeve
Paragon 28, Inc.
P41-942-7080
In Commercial Distribution

  • 00889795107558 ()
P41-942-7080

  • Orthopaedic implantation sleeve, reusable
Ø5.5/6.0 Driver Sleeve
Paragon 28, Inc.
P41-942-5560
In Commercial Distribution

  • 00889795107541 ()
P41-942-5560

  • Orthopaedic implantation sleeve, reusable
Ø4.5/5.0 Driver Sleeve
Paragon 28, Inc.
P41-942-4550
In Commercial Distribution

  • 00889795107534 ()
P41-942-4550

  • Orthopaedic implantation sleeve, reusable
Ø7.0/8.0 Driver, Cannulated
Paragon 28, Inc.
P41-941-7080
In Commercial Distribution

  • 00889795107527 ()
P41-941-7080

  • Fluted surgical drill bit, single-use
Ø5.5/6.0 Driver, Cannulated
Paragon 28, Inc.
P41-941-5560
In Commercial Distribution

  • 00889795107510 ()
P41-941-5560

  • Fluted surgical drill bit, single-use
Ø4.5/5.0 Driver, Cannulated
Paragon 28, Inc.
P41-941-4550
In Commercial Distribution

  • 00889795106315 ()
P41-941-4550

  • Fluted surgical drill bit, single-use
Monster Bite Driver, Disposable Handle
Paragon 28, Inc.
P13-905-0001
In Commercial Distribution

  • 00889795106230 ()
P13-905-0001

  • Surgical screwdriver, reusable
Driver, HX10, Ankle Fx. 360
Paragon 28, Inc.
P99-191-AF10
In Commercial Distribution

  • 00889795099778 ()
P99-191-AF10

  • Surgical screwdriver, reusable
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