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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 - 00889795100252

DECOUPLED TALAR RESECTION, +3MM (C), DUAL SHIM
Paragon 28, Inc.
P10-942-DT03
In Commercial Distribution

  • 00889795100252 ()
P10-942-DT03

  • Orthopaedic prosthesis implantation positioning instrument, reusable

APEX 3D Total Ankle Replacement System - 00889795100245

DECOUPLED TALAR RESECTION, +2MM, DUAL SHIM
Paragon 28, Inc.
P10-942-DT02
In Commercial Distribution

  • 00889795100245 ()
P10-942-DT02

  • Orthopaedic prosthesis implantation positioning instrument, reusable

APEX 3D Total Ankle Replacement System - 00889795100238

DECOUPLED TALAR RESECTION, +1MM, DUAL SHIM
Paragon 28, Inc.
P10-942-DT01
In Commercial Distribution

  • 00889795100238 ()
P10-942-DT01

  • Orthopaedic prosthesis implantation positioning instrument, reusable

Baby Gorilla®/Gorilla® Plating System - 00889795100054

Gorilla Half Height Caddy Tray, Full DIN (Insert)
Paragon 28, Inc.
P50-900-0011
In Commercial Distribution

  • 00889795100054 ()
P50-900-0011

  • Device sterilization/disinfection container, reusable

Baby Gorilla®/Gorilla® Plating System - 00889795100047

Gorilla Half Height Implant Base, Full DIN
Paragon 28, Inc.
P50-900-0010
In Commercial Distribution

  • 00889795100047 ()
P50-900-0010

  • Device sterilization/disinfection container, reusable

TenoTac Soft Tissue Fixation System - 00889795100023

TenoTac Caddy Lid
Paragon 28, Inc.
P42-900-TTAC-2
In Commercial Distribution

  • 00889795100023 ()
P42-900-TTAC-2

  • Device sterilization/disinfection container, reusable

TenoTac Soft Tissue Fixation System - 00889795100016

TenoTac Caddy Base
Paragon 28, Inc.
P42-900-TTAC-1
In Commercial Distribution

  • 00889795100016 ()
P42-900-TTAC-1

  • Device sterilization/disinfection container, reusable

Monster® Screw System - 00889795099839

Monster 7.0mm Combination Headed and Headless Caddy, Base
Paragon 28, Inc.
P20-900-0010-1
In Commercial Distribution

  • 00889795099839 ()
P20-900-0010-1

  • Device sterilization/disinfection container, reusable

Baby Gorilla®/Gorilla® Plating System - 00889795099778

Driver, HX10, Ankle Fx. 360
Paragon 28, Inc.
P99-191-AF10
In Commercial Distribution

  • 00889795099778 ()
P99-191-AF10

  • Surgical screwdriver, reusable

Baby Gorilla®/Gorilla® Plating System - 00889795099723

Gorilla R3CON, Drill Guide, 2.7 Threaded, Locking, SS, Long
Paragon 28, Inc.
P51-900-1004
In Commercial Distribution

  • 00889795099723 ()
P51-900-1004

  • Orthopaedic implantation sleeve, reusable
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