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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 - 00889795146496

1.6mm x 400mm, Entry Guidewire, Ball Tip
Paragon 28, Inc.
P36-912-1641
In Commercial Distribution

  • 00889795146496 ()
P36-912-1641

  • Orthopaedic guidewire, single-use

Phantom® Fibula Nail System - 00889795146304

Phantom Fibula Nail System, Case 1 of 1, Cannulated Reamer Case Base
Paragon 28, Inc.
P36-900-FIB3
In Commercial Distribution

  • 00889795146304 ()
P36-900-FIB3

  • Device sterilization/disinfection container, reusable

Phantom® Fibula Nail System - 00889795146298

1.6mm x 400mm, Sterilization K-Wire Container
Paragon 28, Inc.
P36-913-1640
In Commercial Distribution

  • 00889795146298 ()
P36-913-1640

  • Device sterilization/disinfection container, reusable

Phantom® Fibula Nail System - 00889795146281

6.5mm Proximal Reamer, Cannulated, AO Quick Connect
Paragon 28, Inc.
P36-925-6531
In Commercial Distribution

  • 00889795146281 ()
P36-925-6531

  • Bone-resection orthopaedic reamer, single-use

Phantom® Fibula Nail System - 00889795146267

5.2mm Proximal Reamer, Cannulated, AO Quick Connect
Paragon 28, Inc.
P36-925-5231
In Commercial Distribution

  • 00889795146267 ()
P36-925-5231

  • Bone-resection orthopaedic reamer, single-use

Phantom® Fibula Nail System - 00889795146236

3.3mm Proximal Reamer, Cannulated, AO Quick Connect
Paragon 28, Inc.
P36-925-3331
In Commercial Distribution

  • 00889795146236 ()
P36-925-3331

  • Bone-resection orthopaedic reamer, single-use

Phantom® Fibula Nail System - 00889795146229

1.6mm x 400mm, Entry Guidewire, Trocar
Paragon 28, Inc.
P36-912-1640
In Commercial Distribution

  • 00889795146229 ()
P36-912-1640

  • Orthopaedic guidewire, single-use

APEX 3D S Total Ankle Replacement System - 00889795146182

Short Stem Tibia System, Instrument, Drill Caddy Lid
Paragon 28, Inc.
P11-900-0004
In Commercial Distribution

  • 00889795146182 ()
P11-900-0004

  • Device sterilization/disinfection container, reusable

Monkey Bars™ Pin to Bar External Fixation System - 00889795145956

T-Handle, AO and 10mm Socket
Paragon 28, Inc.
P47-940-0001
In Commercial Distribution

  • 00889795145956 ()
P47-940-0001

  • Surgical instrument handle, non-torque-limiting

Monkey Bars™ Pin to Bar External Fixation System - 00889795145949

5mm Trocar
Paragon 28, Inc.
P47-930-0001
In Commercial Distribution

  • 00889795145949 ()
P47-930-0001

  • Orthopaedic prosthesis implantation positioning instrument, reusable
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