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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, 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, Alignment, Tray
Paragon 28, Inc.
P10-900-0001
In Commercial Distribution

  • 00889795098955 ()
P10-900-0001

  • Device sterilization/disinfection container, reusable
Total Ankle, Instrument, Alignment, Guide, PSI Alignment Rod
Paragon 28, Inc.
P10-941-PSI1
In Commercial Distribution

  • 00889795098948 ()
P10-941-PSI1

  • Orthopaedic fixation implant alignment tool
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
Total Ankle, Instrument, Socket Driver
Paragon 28, Inc.
P10-910-SCKT
In Commercial Distribution

  • 00889795098924 ()
P10-910-SCKT

  • Surgical screwdriver, reusable
Phantom Hindfoot TTC/TC Nail, Reamer Caddy, Case 2 of 3
Paragon 28, Inc.
P31-902-RMCD
In Commercial Distribution

  • 00889795098382 ()
P31-902-RMCD

  • Device sterilization/disinfection container, reusable
Phantom Hindfoot TTC/TC Nail, Tray 2, Case 2 of 3
Paragon 28, Inc.
P31-902-TRY2
In Commercial Distribution

  • 00889795098375 ()
P31-902-TRY2

  • Device sterilization/disinfection container, reusable
Phantom Hindfoot TTC/TC Nail, Tray 1, Case 2 of 3
Paragon 28, Inc.
P31-902-TRY1
In Commercial Distribution

  • 00889795098368 ()
P31-902-TRY1

  • Device sterilization/disinfection container, reusable
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