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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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VSP System - 00816847020565

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

VSP System - 00816847020558

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

VSP System - 00816847020541

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

VSP System - 00816847020534

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

VSP System - 00816847020527

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

VSP System - 00816847020510

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

DJO SURGICAL - 00888912126250

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

  • 00888912126250 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

Monkey Rings™ External Fixation System - 00889795117960

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

Monkey Rings™ External Fixation System - 00889795116482

Hex Driver on T Handle
Paragon 28, Inc.
P45-515-0001
In Commercial Distribution

  • 00889795116482 ()
P45-515-0001

  • Surgical screwdriver, reusable

Monkey Bars™ Pin to Bar External Fixation System - 00889795114914

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

  • 00889795114914 ()
P47-940-0001

  • Surgical instrument handle, non-torque-limiting
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