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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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FJ-2000, MIS Hand Piece and AO Connection Kit (Sterile)
Paragon 28, Inc.
P65-001-0001-SK
In Commercial Distribution

  • 00889795131041 ()
P65-001-0001-SK

  • Surgical power tool system control unit, line-powered
Saw Blade 39 x 10 x 0.4/0.6mm, Stryker (Sterile)
Paragon 28, Inc.
P99-151-P302-S
In Commercial Distribution

  • 00889795129055 ()
P99-151-P302-S

  • Surgical saw blade, sagittal, single-use
Saw Blade 39 x 10 x 0.4/0.6mm, MicroAire (Sterile)
Paragon 28, Inc.
P99-151-P301-S
In Commercial Distribution

  • 00889795129048 ()
P99-151-P301-S

  • Surgical saw blade, sagittal, single-use
Tendon Harvester & Dilator Sterile Kit
Paragon 28, Inc.
P68-101-0000-SK
In Commercial Distribution

  • 00889795128751 ()
P68-101-0000-SK

  • Orthopaedic surgical procedure kit, non-medicated, reusable
R3ACT Synds Imp 4.2x62mm, 17mm Ntch, St
Paragon 28, Inc.
P80-142-1762-S
In Commercial Distribution

  • 00889795128713 ()
P80-142-1762-S

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile
R3ACT Synds Imp 4.2x57mm, 17mm Ntch, St
Paragon 28, Inc.
P80-142-1757-S
In Commercial Distribution

  • 00889795128706 ()
P80-142-1757-S

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile
R3ACT Synds Imp 4.2x52mm, 17mm Ntch, St
Paragon 28, Inc.
P80-142-1752-S
In Commercial Distribution

  • 00889795128690 ()
P80-142-1752-S

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile
R3ACT Synds Imp 4.2x47mm, 17mm Ntch, St
Paragon 28, Inc.
P80-142-1747-S
In Commercial Distribution

  • 00889795128683 ()
P80-142-1747-S

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile
R3ACT Synds Imp 4.2x62mm, 14mm Ntch, St
Paragon 28, Inc.
P80-142-1462-S
In Commercial Distribution

  • 00889795128676 ()
P80-142-1462-S

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile
R3ACT Synds Imp 4.2x57mm, 14mm Ntch, St
Paragon 28, Inc.
P80-142-1457-S
In Commercial Distribution

  • 00889795128669 ()
P80-142-1457-S

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile
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