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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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FJ2000 System - 00889795131195

FJ-2000, Minimally Invasive Procedure and Open Kit (Sterile)
Paragon 28, Inc.
P65-001-0005-SK
In Commercial Distribution

  • 00889795131195 ()
P65-001-0005-SK

  • Surgical power tool system control unit, line-powered

FJ2000 System - 00889795131188

Saw Blade, 9 x 31 x .051mm, OrthoCircle (Sterile)
Paragon 28, Inc.
P65-151-P300-S
In Commercial Distribution

  • 00889795131188 ()
P65-151-P300-S

  • Surgical power tool system control unit, line-powered

FJ2000 System - 00889795131171

FJ-2000, Open Procedure with Sagittal Saw Kit (Sterile)
Paragon 28, Inc.
P65-001-0004-SK
In Commercial Distribution

  • 00889795131171 ()
P65-001-0004-SK

  • Surgical power tool system control unit, line-powered

FJ2000 System - 00889795131164

FJ-2000, High Speed Handpiece with Sagittal Saw Kit (Sterile)
Paragon 28, Inc.
P65-001-0003-SK
In Commercial Distribution

  • 00889795131164 ()
P65-001-0003-SK

  • Surgical power tool system control unit, line-powered

FJ2000 System - 00889795131157

FJ-2000, MIS Instrument Kit (Sterile)
Paragon 28, Inc.
P65-001-0007-SK
In Commercial Distribution

  • 00889795131157 ()
P65-001-0007-SK

  • Surgical power tool system control unit, line-powered

FJ2000 System - 00889795131140

FJ-2000, MIS Irrigation Kit (Sterile)
Paragon 28, Inc.
P65-001-0006-SK
In Commercial Distribution

  • 00889795131140 ()
P65-001-0006-SK

  • Surgical power tool system control unit, line-powered

FJ2000 System - 00889795131133

Wedge Bone Burr, 4.3 x 13 x 72, AO (Sterile)
Paragon 28, Inc.
P65-108-4313-S
In Commercial Distribution

  • 00889795131133 ()
P65-108-4313-S

  • Orthopaedic bur, single-use

FJ2000 System - 00889795131126

Wedge Bone Burr, 2.9 x 13 x 72, AO (Sterile)
Paragon 28, Inc.
P65-108-2913-S
In Commercial Distribution

  • 00889795131126 ()
P65-108-2913-S

  • Orthopaedic bur, single-use

FJ2000 System - 00889795131119

Shannon-style Recta Bone Burr, 3.0 x 30 x 82, AO (Sterile)
Paragon 28, Inc.
P65-105-3030-S
In Commercial Distribution

  • 00889795131119 ()
P65-105-3030-S

  • Orthopaedic bur, single-use

FJ2000 System - 00889795131102

Shannon-style Recta Bone Burr, 2.2 x 20 x 82, AO (Sterile)
Paragon 28, Inc.
P65-105-2221-S
In Commercial Distribution

  • 00889795131102 ()
P65-105-2221-S

  • Orthopaedic bur, single-use
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