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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 - 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

APEX 3D Total Ankle Replacement System - 00889795062055

APEX 3D-PS Total Ankle Replacement System, Trial Tibia, ARC, Size 2, Right
Paragon 28, Inc.
P10-910-TB2R
In Commercial Distribution

  • 00889795062055 ()
P10-910-TB2R

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795062048

APEX 3D-PS Total Ankle Replacement System, Trial Tibia, ARC, Size 2, Left
Paragon 28, Inc.
P10-910-TB2L
In Commercial Distribution

  • 00889795062048 ()
P10-910-TB2L

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795062031

APEX 3D-PS Total Ankle Replacement System, Trial Tibia, ARC, Size 1, Right
Paragon 28, Inc.
P10-910-TB1R
In Commercial Distribution

  • 00889795062031 ()
P10-910-TB1R

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795062024

APEX 3D-PS Total Ankle Replacement System, Trial Tibia, ARC, Size 1, Left
Paragon 28, Inc.
P10-910-TB1L
In Commercial Distribution

  • 00889795062024 ()
P10-910-TB1L

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795062017

APEX 3D-PS Total Ankle Replacement System, 3.0 Pin, 316LVM, Fluted, 160mm
Paragon 28, Inc.
P10-902-3016
In Commercial Distribution

  • 00889795062017 ()
P10-902-3016

  • Orthopaedic bone wire
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