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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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Anterior Mini-Open Plate, Medial Precision Guide, Tibiotalar Joint
Paragon 28, Inc.
P51-983-5001
In Commercial Distribution

  • 00889795113832 ()
P51-983-5001

  • Orthopaedic fixation implant alignment tool
Silverback Mini Open Caddy Base
Paragon 28, Inc.
P50-900-SBMIN
In Commercial Distribution

  • 00889795113818 ()
P50-900-SBMIN

  • Device sterilization/disinfection container, reusable
R3ACT Suture Release Guide Tube
Paragon 28, Inc.
P80-940-3903
In Commercial Distribution

  • 00889795113788 ()
P80-940-3903

  • Orthopaedic fixation implant alignment tool
Pilot Nose Drill Stop Tube, 17mm Depth
Paragon 28, Inc.
P80-930-32PN-17
In Commercial Distribution

  • 00889795113771 ()
P80-930-32PN-17

  • Cannulated surgical drill bit, reusable
Pilot Nose Drill Stop Tube, 14mm Depth
Paragon 28, Inc.
P80-930-32PN-14
In Commercial Distribution

  • 00889795113764 ()
P80-930-32PN-14

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

  • 00889795113757 ()
P80-940-3904

  • Surgical screwdriver, reusable
Torque Limiting Handle, 8 in.-lb., petite
Paragon 28, Inc.
P99-000-TQ08
In Commercial Distribution

  • 00889795113733 ()
P99-000-TQ08

  • Surgical instrument handle, torque-limiting
Ø2.8mm Drill Cone Guide
Paragon 28, Inc.
P80-930-2800
In Commercial Distribution

  • 00889795113726 ()
P80-930-2800

  • Orthopaedic fixation implant alignment tool
Ø3.2mm Solid Drill with Ø2.8mm Pilot Nose
Paragon 28, Inc.
P80-900-32PN
In Commercial Distribution

  • 00889795113719 ()
P80-900-32PN

  • Cannulated surgical drill bit, reusable
TOTAL ANKLE, INSTRUMENTS, AP DEPTH GAUGE, SIZE 5
Paragon 28, Inc.
P10-942-APD5
In Commercial Distribution

  • 00889795113559 ()
P10-942-APD5

  • Surgical depth gauge, reusable
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