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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 Total Ankle Replacement System - 00889795061997

APEX 3D-PS Total Ankle Replacement System, 2.4 Shoulder-Thread Pin, 50mm Thread length
Paragon 28, Inc.
P10-902-2450
In Commercial Distribution

  • 00889795061997 ()
P10-902-2450

  • Orthopaedic bone wire

APEX 3D Total Ankle Replacement System - 00889795061973

APEX 3D-PS Total Ankle Replacement System, Tibial Rasp, ARC, Size 6
Paragon 28, Inc.
P10-901-RSP6
In Commercial Distribution

  • 00889795061973 ()
P10-901-RSP6

  • Bone file/rasp, manual, reusable

APEX 3D Total Ankle Replacement System - 00889795061966

APEX 3D-PS Total Ankle Replacement System, Tibial Rasp, ARC, Size 5
Paragon 28, Inc.
P10-901-RSP5
In Commercial Distribution

  • 00889795061966 ()
P10-901-RSP5

  • Bone file/rasp, manual, reusable

APEX 3D Total Ankle Replacement System - 00889795061935

APEX 3D-PS Total Ankle Replacement System, Tibial Rasp, ARC, Size 2
Paragon 28, Inc.
P10-901-RSP2
In Commercial Distribution

  • 00889795061935 ()
P10-901-RSP2

  • Bone file/rasp, manual, reusable

APEX 3D Total Ankle Replacement System - 00889795061928

APEX 3D-PS Total Ankle Replacement System, Tibial Rasp, ARC, Size 1
Paragon 28, Inc.
P10-901-RSP1
In Commercial Distribution

  • 00889795061928 ()
P10-901-RSP1

  • Bone file/rasp, manual, reusable

APEX 3D Total Ankle Replacement System - 00889795061843

APEX 3D-PS Total Ankle Replacement System, T-Handle
Paragon 28, Inc.
P10-901-24TH
In Commercial Distribution

  • 00889795061843 ()
P10-901-24TH

  • Surgical instrument handle, non-torque-limiting

Monster Screw System - 00889795016447

Monster BITE, Driver, AO
Paragon 28, Inc.
P24-905-0001
In Commercial Distribution

  • 00889795016447 ()
P24-905-0001

  • Surgical screwdriver, reusable

Monster Screw System - 00889795016423

Monster BITE Caddy, Insert
Paragon 28, Inc.
P24-900-BITE-2
In Commercial Distribution

  • 00889795016423 ()
P24-900-BITE-2

  • Device sterilization/disinfection container, reusable

Monster Screw System - 00889795016416

Monster BITE Caddy, Base
Paragon 28, Inc.
P24-900-BITE-1
In Commercial Distribution

  • 00889795016416 ()
P24-900-BITE-1

  • Device sterilization/disinfection container, reusable

Monster Screw System - 00889795016409

7.0 mm Monster Screw Tap
Paragon 28, Inc.
P20-920-7000
In Commercial Distribution

  • 00889795016409 ()
P20-920-7000

  • Bone tap, reusable
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