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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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2.6mm Proximal Reamer, Solid, AO Quick Connect
Paragon 28, Inc.
P36-915-2632
In Commercial Distribution

  • 00889795136992 ()
P36-915-2632

  • Bone-resection orthopaedic reamer, single-use
2.0mm x 150mm, Trocar K-Wire
Paragon 28, Inc.
P36-912-2015
In Commercial Distribution

  • 00889795136961 ()
P36-912-2015

  • Orthopaedic guidewire, single-use
1.6mm x 230mm, Entry Guidewire, Trocar
Paragon 28, Inc.
P36-912-1623
In Commercial Distribution

  • 00889795136954 ()
P36-912-1623

  • Orthopaedic guidewire, single-use
Short Stem Tibia, Instrument, Tibial Docking Fixture, Sizes 1-2
Paragon 28, Inc.
P11-810-TB12
In Commercial Distribution

  • 00889795136930 ()
P11-810-TB12

  • Fixed-bearing total ankle prosthesis
Short Stem Tibia, Instrument, Drill Bit, Pilot, D9 x H7.5
Paragon 28, Inc.
P11-854-D09S
In Commercial Distribution

  • 00889795136923 ()
P11-854-D09S

  • Cannulated surgical drill bit, single-use
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
Short Stem Tibia, Instrument, Drill Bit Cap D12, Tall
Paragon 28, Inc.
P11-854-C12T
In Commercial Distribution

  • 00889795136893 ()
P11-854-C12T

  • Cannulated surgical drill bit, single-use
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
Short Stem Tibia, Instrument, Drill Bit Cap D10.5, Tall
Paragon 28, Inc.
P11-854-C10T
In Commercial Distribution

  • 00889795136879 ()
P11-854-C10T

  • Cannulated surgical drill bit, single-use
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
Short Stem Tibia, Instrument, Drill Bit Cap D9, Tall
Paragon 28, Inc.
P11-854-C09T
In Commercial Distribution

  • 00889795136824 ()
P11-854-C09T

  • Cannulated surgical drill bit, single-use
Special Instrument, Straight Nail Short Dual Calc Screw Guide Assembly
Paragon 28, Inc.
SP31-950-0007
In Commercial Distribution

  • 00889795151780 ()
SP31-950-0007

  • Surgical drill guide, reusable
Special Instrument, Straight Nail Short Calc Screw K-wire Guide
Paragon 28, Inc.
SP31-950-0006
In Commercial Distribution

  • 00889795151773 ()
SP31-950-0006

  • Surgical drill guide, reusable
Special Instrument, Straight Nail Short Calc Screw Drill Guide
Paragon 28, Inc.
SP31-950-0004
In Commercial Distribution

  • 00889795151766 ()
SP31-950-0004

  • Surgical drill guide, reusable
Special Instrument, Precision MIS Drill/K-wire Guide, 3.5 Screw
Paragon 28, Inc.
SP27-943-0035
In Commercial Distribution

  • 00889795150042 ()
SP27-943-0035

  • Surgical drill guide, reusable
Special Instrument, Precision MIS Drill/K-wire Guide, 3.0 Screw
Paragon 28, Inc.
SP27-943-0030
In Commercial Distribution

  • 00889795150035 ()
SP27-943-0030

  • Surgical drill guide, reusable
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)
MIS Chamfer Screw, 5mm Reduction Wire
Paragon 28, Inc.
SP27-182-0005
In Commercial Distribution

  • 00889795146625 ()
SP27-182-0005

  • Orthopaedic guidewire, single-use
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
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
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