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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 - 00889795136961

2.0mm x 150mm, Trocar K-Wire
Paragon 28, Inc.
P36-912-2015
In Commercial Distribution

  • 00889795136961 ()
P36-912-2015

  • 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 S Total Ankle Replacement System - 00889795136824

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

Monster Screw System - 00889795016430

Monster BITE Caddy, Lid
Paragon 28, Inc.
P24-900-BITE-3
In Commercial Distribution

  • 00889795016430 ()
P24-900-BITE-3

  • Device sterilization/disinfection container, reusable

Monster Screw System - 00889795016423

Monster BITE Caddy, Insert
Paragon 28, Inc.
P24-900-BITE-2
In Commercial Distribution

  • 00889795016423 ()
P24-900-BITE-2

  • Device sterilization/disinfection container, reusable

Monster Screw System - 00889795016416

Monster BITE Caddy, Base
Paragon 28, Inc.
P24-900-BITE-1
In Commercial Distribution

  • 00889795016416 ()
P24-900-BITE-1

  • Device sterilization/disinfection container, reusable

Monster Screw System - 00889795016409

7.0 mm Monster Screw Tap
Paragon 28, Inc.
P20-920-7000
In Commercial Distribution

  • 00889795016409 ()
P20-920-7000

  • Bone tap, reusable

Monster Screw System - 00889795016393

5.5 mm Monster Screw Tap
Paragon 28, Inc.
P20-920-5500
In Commercial Distribution

  • 00889795016393 ()
P20-920-5500

  • Bone tap, reusable

Monster Screw System - 00889795016386

4.5 mm Monster Screw Tap
Paragon 28, Inc.
P20-920-4500
In Commercial Distribution

  • 00889795016386 ()
P20-920-4500

  • Bone tap, reusable
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