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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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APEX 3D-PS Total Ankle Replacement System, Impaction, Tray
Paragon 28, Inc.
P10-900-0005
In Commercial Distribution

  • 00889795098993 ()
P10-900-0005

  • Device sterilization/disinfection container, reusable
APEX 3D-PS Total Ankle Replacement System, Talus Trialing, Tray
Paragon 28, Inc.
P10-900-0004
In Commercial Distribution

  • 00889795098986 ()
P10-900-0004

  • Device sterilization/disinfection container, reusable
APEX 3D-PS Total Ankle Replacement System, Tibia Trialing, Tray
Paragon 28, Inc.
P10-900-0003
In Commercial Distribution

  • 00889795098979 ()
P10-900-0003

  • Device sterilization/disinfection container, reusable
APEX 3D-PS Total Ankle Replacement System, Resection, Tray
Paragon 28, Inc.
P10-900-0002
In Commercial Distribution

  • 00889795098962 ()
P10-900-0002

  • Device sterilization/disinfection container, reusable
APEX 3D-PS Total Ankle Replacement System, Poly Insertion Tool
Paragon 28, Inc.
P10-951-IN02
In Commercial Distribution

  • 00889795098931 ()
P10-951-IN02

  • Orthopaedic inorganic implant inserter/extractor, reusable
Dynamic Syndesmosis Screw Ø4.2 X 60mm, 17mm Notch, Sterile
Paragon 28, Inc.
P80-142-1760-S
In Commercial Distribution

  • 00889795098481 ()
P80-142-1760-S

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile
Dynamic Syndesmosis Screw Ø4.2 X 50mm, 17mm Notch, Sterile
Paragon 28, Inc.
P80-142-1750-S
In Commercial Distribution

  • 00889795098467 ()
P80-142-1750-S

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile
Dynamic Syndesmosis Screw Ø4.2 X 45mm, 17mm Notch, Sterile
Paragon 28, Inc.
P80-142-1745-S
In Commercial Distribution

  • 00889795098450 ()
P80-142-1745-S

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile
Dynamic Syndesmosis Screw Ø4.2 X 60mm, 14mm Notch, Sterile
Paragon 28, Inc.
P80-142-1460-S
In Commercial Distribution

  • 00889795098436 ()
P80-142-1460-S

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile
Dynamic Syndesmosis Screw Ø4.2 X 50mm, 14mm Notch, Sterile
Paragon 28, Inc.
P80-142-1450-S
In Commercial Distribution

  • 00889795098412 ()
P80-142-1450-S

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile
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