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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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3.9mm Proximal Reamer, Solid, AO Quick Connect
Paragon 28, Inc.
P36-915-3931
In Commercial Distribution

  • 00889795137012 ()
P36-915-3931

  • Bone-resection orthopaedic reamer, single-use
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
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
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 D10.5, Tall
Paragon 28, Inc.
P11-854-C10T
In Commercial Distribution

  • 00889795136879 ()
P11-854-C10T

  • Cannulated surgical drill bit, single-use
Screw Driver Attachment 7.0/8.0mm, Solid , A/O, Trilobe, Grappler
Paragon 28, Inc.
P41-940-7080
In Commercial Distribution

  • 00889795057549 ()
P41-940-7080

  • Surgical screwdriver, reusable
Screw Driver Attachment 4.5/5.0mm, Solid , A/O, Trilobe, Grappler
Paragon 28, Inc.
P41-940-4550
In Commercial Distribution

  • 00889795057525 ()
P41-940-4550

  • Surgical screwdriver, reusable
Tissue Protector Insert 8.5, Grappler
Paragon 28, Inc.
P41-930-8500
In Commercial Distribution

  • 00889795057501 ()
P41-930-8500

  • Orthopaedic implantation sleeve, reusable
Tissue Protector Insert 7.5, Grappler
Paragon 28, Inc.
P41-930-7500
In Commercial Distribution

  • 00889795057488 ()
P41-930-7500

  • Orthopaedic implantation sleeve, reusable
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