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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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Baby Gorilla® / Gorilla® Plating System - 00889795150004

Gorilla®, R3CON™ Screw, Ø2.7 x 72mm, Non-Locking, Solid, TiA
Paragon 28, Inc.
P50-453-2772
In Commercial Distribution

  • 00889795150004 ()
P50-453-2772

  • Orthopaedic bone screw (non-sliding)

Specialty Instrument - 00889795146625

MIS Chamfer Screw, 5mm Reduction Wire
Paragon 28, Inc.
SP27-182-0005
In Commercial Distribution

  • 00889795146625 ()
SP27-182-0005

  • Orthopaedic guidewire, single-use

Preserve Bone Wedge Trials - 00889795146601

3D Printed Lapidus Trial, 4mm, 0Deg
Paragon 28, Inc.
PLT-3DP-0004
In Commercial Distribution

  • 00889795146601 ()
PLT-3DP-0004

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

Preserve Bone Wedge Trials - 00889795146595

3D Printed Evans Trial, 4mm
Paragon 28, Inc.
PET-3DP-0004
In Commercial Distribution

  • 00889795146595 ()
PET-3DP-0004

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

Preserve Bone Wedge Trials - 00889795146588

3D Printed Cotton Trial, 10mm
Paragon 28, Inc.
PCT-3DP-0010
In Commercial Distribution

  • 00889795146588 ()
PCT-3DP-0010

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

Preserve Bone Wedge Trials - 00889795146571

3D Printed Cotton Trial, 9mm
Paragon 28, Inc.
PCT-3DP-0009
In Commercial Distribution

  • 00889795146571 ()
PCT-3DP-0009

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

Special Instrument - 00889795146564

Specialty Instrument, Metatarsal Pusher
Paragon 28, Inc.
SP27-102-1000
In Commercial Distribution

  • 00889795146564 ()
SP27-102-1000

  • Orthopaedic prosthesis implantation positioning instrument, reusable

Grappler Interference Screw System - 00889795146502

PCFD Tether, System Tray, Lid
Paragon 28, Inc.
P62-CAD-0002
In Commercial Distribution

  • 00889795146502 ()
P62-CAD-0002

  • Device sterilization/disinfection container, reusable

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
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