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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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Total Ankle, Instrument, Viper Punch, GEN II, Size 2
Paragon 28, Inc.
P10-851-TBV2
In Commercial Distribution

  • 00889795113894 ()
P10-851-TBV2

  • Bone-coring punch, reusable
Total Ankle, Instrument, Viper Punch, GEN II, Size 1
Paragon 28, Inc.
P10-851-TBV1
In Commercial Distribution

  • 00889795113887 ()
P10-851-TBV1

  • Bone-coring punch, reusable
Anterior Mini-Open Plate, Precision Guide Arm Base, Flat
Paragon 28, Inc.
P51-983-5005
In Commercial Distribution

  • 00889795113870 ()
P51-983-5005

  • Orthopaedic fixation implant alignment tool
Anterior Mini-Open Plate, Precision Guide Arm Base, Contoured
Paragon 28, Inc.
P51-983-5004
In Commercial Distribution

  • 00889795113863 ()
P51-983-5004

  • Orthopaedic fixation implant alignment tool
Anterior Mini-Open Plate, Joystick
Paragon 28, Inc.
P51-983-5003
In Commercial Distribution

  • 00889795113856 ()
P51-983-5003

  • Orthopaedic fixation implant alignment tool
Anterior Mini-Open Plate, Lateral Precision Guide, Tibiotalar Joint
Paragon 28, Inc.
P51-983-5002
In Commercial Distribution

  • 00889795113849 ()
P51-983-5002

  • Orthopaedic fixation implant alignment tool
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
Ø0.90mm Drill Point K-Wire
Paragon 28, Inc.
P99-307-0910
In Commercial Distribution

  • 00889795113740 ()
P99-307-0910

  • Orthopaedic bone wire
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
Ø1.60mm X 10cm Olive Wire, Threaded, 316 LVM
Paragon 28, Inc.
P99-251-1610
In Commercial Distribution

  • 00889795113702 ()
P99-251-1610

  • Orthopaedic bone wire
Ø1.60mm X 8cm Olive Wire, Threaded, 316 LVM
Paragon 28, Inc.
P99-251-1608
In Commercial Distribution

  • 00889795113696 ()
P99-251-1608

  • Orthopaedic bone wire
Ø2.0mm x 15cm Threaded, K-Wire
Paragon 28, Inc.
P99-193-2015
In Commercial Distribution

  • 00889795113689 ()
P99-193-2015

  • Orthopaedic bone wire
Gorilla, R3CON, Locking Screw, Compact Thread, Ø3.50 x 18mm
Paragon 28, Inc.
P50-753-3518
In Commercial Distribution

  • 00889795113672 ()
P50-753-3518

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
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