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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 - 00889795111517

MAVEN, TOTAL ANKLE, PSI, TIBIA BONE MODEL, LEFT
Paragon 28, Inc.
P10-PSI-L101
In Commercial Distribution

  • 00889795111517 ()
P10-PSI-L101

  • Custom-made orthopaedic/craniofacial surgical guide

R3ACT Stabilization System - 00889795111388

R3ACT Caddy Lid
Paragon 28, Inc.
P80-900-0004-2
In Commercial Distribution

  • 00889795111388 ()
P80-900-0004-2

  • Device sterilization/disinfection container, reusable

R3ACT Stabilization System - 00889795111371

R3ACT Caddy
Paragon 28, Inc.
P80-900-0004-1
In Commercial Distribution

  • 00889795111371 ()
P80-900-0004-1

  • Device sterilization/disinfection container, reusable

APEX 3D Total Ankle Replacement System - 00889795111340

Curette, 9mm, 45 Degrees
Paragon 28, Inc.
P99-150-0098
In Commercial Distribution

  • 00889795111340 ()
P99-150-0098

  • Bone curette, reusable

Baby Gorilla®/Gorilla® Plating System - 00889795111326

Ankle Fracture, Hook Plate Inserter
Paragon 28, Inc.
P51-922-1006
In Commercial Distribution

  • 00889795111326 ()
P51-922-1006

  • Orthopaedic implant aiming/guiding block attachment tool

Baby Gorilla®/Gorilla® Plating System - 00889795111319

Periosteal Elevator
Paragon 28, Inc.
P99-150-2004
In Commercial Distribution

  • 00889795111319 ()
P99-150-2004

  • Periosteal elevator, reusable

Baby Gorilla®/Gorilla® Plating System - 00889795111302

Langenbeck Elevator
Paragon 28, Inc.
P99-150-2003
In Commercial Distribution

  • 00889795111302 ()
P99-150-2003

  • Periosteal elevator, reusable

Baby Gorilla®/Gorilla® Plating System - 00889795111296

Fracture Reduction Clamp (Pig Sticker)
Paragon 28, Inc.
P99-150-0134
In Commercial Distribution

  • 00889795111296 ()
P99-150-0134

  • Bone approximation clamp

Baby Gorilla®/Gorilla® Plating System - 00889795111289

Gorilla, Ankle Fracture, Hook Plate Template, Lateral Mal.
Paragon 28, Inc.
P51-922-1005
In Commercial Distribution

  • 00889795111289 ()
P51-922-1005

  • Surgical implant template, reusable

MgNum - 00889795110992

MgNum, Bone Void Filler, 15cc
Paragon 28, Inc.
P02-BVF-0015
In Commercial Distribution

  • 00889795110992 ()
P02-BVF-0015

  • Bone matrix implant, synthetic, non-antimicrobial
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