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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, Power Console with Irrigation Pump
Paragon 28, Inc.
P65-002-0001
In Commercial Distribution

  • 00889795131201 ()
P65-002-0001

  • Surgical power tool system control unit, line-powered
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
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
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
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
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
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
FJ-2000, Minimally Invasive Procedure Kit for Hardware (Sterile)
Paragon 28, Inc.
P65-001-0002-SK
In Commercial Distribution

  • 00889795131058 ()
P65-001-0002-SK

  • Surgical power tool system control unit, line-powered
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
DYONICS POWERMAX ELITE HANDPIECE WITH BLADE MULTI-POSITIONING, HAND CONTROLS, SUCTION LEVER, 10 FT 3 M CORD, SERVICE REPLACEMENT
Smith & Nephew, Inc.
72200616S
In Commercial Distribution

  • 03596010565105 ()
72200616S

  • Surgical power tool system control unit, line-powered
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