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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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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 - 00889795137104

4.0mm Single Lead Tap, AO Quick Connect
Paragon 28, Inc.
P36-921-4018
In Commercial Distribution

  • 00889795137104 ()
P36-921-4018

  • Bone tap, single-use

Phantom® Fibula Nail System - 00889795137081

3.2mm R3ACT Drill Bit, 17mm Calibrated, AO Quick Connect
Paragon 28, Inc.
P36-910-3217
In Commercial Distribution

  • 00889795137081 ()
P36-910-3217

  • Fluted surgical drill bit, 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

APEX 3D S Total Ankle Replacement System - 00889795136909

2.4 Threaded Shoulder Pin - Short Shank - 50mm Thread Length
Paragon 28, Inc.
P10-912-2450
In Commercial Distribution

  • 00889795136909 ()
P10-912-2450

  • Orthopaedic guidewire, single-use

APEX 3D S Total Ankle Replacement System - 00889795136886

Short Stem Tibia, Instrument, Drill Bit Cap D12, Short
Paragon 28, Inc.
P11-854-C12S
In Commercial Distribution

  • 00889795136886 ()
P11-854-C12S

  • Cannulated surgical drill bit, single-use

APEX 3D S Total Ankle Replacement System - 00889795136862

Short Stem Tibia, Instrument, Drill Bit Cap D10.5, Short
Paragon 28, Inc.
P11-854-C10S
In Commercial Distribution

  • 00889795136862 ()
P11-854-C10S

  • Cannulated surgical drill bit, single-use

Phantom Hindfoot TTC/TC Nail System - 00889795061836

Phantom TTC Nail, 13.0 X 250mm, RIGHT
Paragon 28, Inc.
P31-330-250R-S
In Commercial Distribution

  • 00889795061836 ()
P31-330-250R-S

  • Arthrodesis intramedullary nail, non-distracting

Phantom Hindfoot TTC/TC Nail System - 00889795061829

Phantom TTC Nail, 13.0 X 250mm, LEFT
Paragon 28, Inc.
P31-330-250L-S
In Commercial Distribution

  • 00889795061829 ()
P31-330-250L-S

  • Arthrodesis intramedullary nail, non-distracting

Phantom Hindfoot TTC/TC Nail System - 00889795061812

Phantom TTC Nail, 13.0 X 200mm, RIGHT
Paragon 28, Inc.
P31-330-200R-S
In Commercial Distribution

  • 00889795061812 ()
P31-330-200R-S

  • Arthrodesis intramedullary nail, non-distracting
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