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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 S Total Ankle Replacement System - 00889795140326

Short Stem Tibia, Instrument, Trial Holder
Paragon 28, Inc.
P11-810-TH01
In Commercial Distribution

  • 00889795140326 ()
P11-810-TH01

  • Surgical implant/trial-implant/sizer holder, reusable

APEX 3D S Total Ankle Replacement System - 00889795140265

Short Stem Tibia, Instrument, Graft impactor - D12
Paragon 28, Inc.
P11-851-GR03
In Commercial Distribution

  • 00889795140265 ()
P11-851-GR03

  • Orthopaedic implant impactor, reusable

APEX 3D S Total Ankle Replacement System - 00889795140241

Short Stem Tibia, Instrument, Graft impactor - D9
Paragon 28, Inc.
P11-851-GR01
In Commercial Distribution

  • 00889795140241 ()
P11-851-GR01

  • Orthopaedic implant impactor, reusable

Bun-Yo-Matic™ Lapidus Clamp System - 00889795140142

K-wire Tube, 100mm MAX
Paragon 28, Inc.
P31-941-0100
In Commercial Distribution

  • 00889795140142 ()
P31-941-0100

  • Device sterilization/disinfection container, reusable

Phantom® Fibula Nail System - 00889795137180

1.6mm x 70mm, Sterilization K-Wire Container
Paragon 28, Inc.
P36-913-1670
In Commercial Distribution

  • 00889795137180 ()
P36-913-1670

  • Device sterilization/disinfection container, reusable

Phantom® Fibula Nail System - 00889795137159

2.3mm x 230mm, Sterilization K-Wire Container
Paragon 28, Inc.
P36-913-2323
In Commercial Distribution

  • 00889795137159 ()
P36-913-2323

  • Device sterilization/disinfection container, reusable

Phantom® Fibula Nail System - 00889795137128

1.6mm x 230mm, Sterilization K-Wire Container
Paragon 28, Inc.
P36-913-1623
In Commercial Distribution

  • 00889795137128 ()
P36-913-1623

  • Device sterilization/disinfection container, reusable

Phantom® Fibula Nail System - 00889795137111

Removal Hook, Body
Paragon 28, Inc.
P36-970-0006
In Commercial Distribution

  • 00889795137111 ()
P36-970-0006

  • Bone hook

Phantom® Fibula Nail System - 00889795137098

Screw Countersink, AO Quick Connect
Paragon 28, Inc.
P36-911-2735
In Commercial Distribution

  • 00889795137098 ()
P36-911-2735

  • Surgical countersink, single-use

Phantom® Fibula Nail System - 00889795137067

2.5mm Drill Bit, Calibrated, AO Quick Connect
Paragon 28, Inc.
P36-910-2519
In Commercial Distribution

  • 00889795137067 ()
P36-910-2519

  • Fluted surgical drill bit, single-use
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