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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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P-K Titanium Motility Peg System - 00854066006236

Titanium Threaded Sleeve Driver (Wrench) used with IOI's Titanium Threaded Sleeve/Flat Peg (I00045) and Titanium Large Threaded Sleeve/Flat Peg (I00100). Manual, single-use, nonsterile surgical instrument.
INTEGRATED ORBITAL IMPLANTS INC
I00057
In Commercial Distribution

  • 00854066006236 ()


  • Surgical screwdriver, reusable

OrthAlign Plus - 00851977007949

Pin Driver, Tri-Flat, 4.0mm
Orthalign, Inc.
403389
In Commercial Distribution

  • 00851977007949 ()
403389

  • Orthopaedic surgical procedure kit, non-medicated, reusable

OrthAlign Plus - 00851977007857

Adapter Socket Driver
Orthalign, Inc.
403347
In Commercial Distribution

  • 00851977007857 ()
403347

  • Orthopaedic surgical procedure kit, non-medicated, reusable

OrthAlign Plus - 00851977007659

6mm Hex Driver
Orthalign, Inc.
403351
In Commercial Distribution

  • 00851977007659 ()
403351

  • Orthopaedic surgical procedure kit, non-medicated, reusable

OrthAlign Plus - 00851977007642

6MM Hex Driver - Purchased
Orthalign, Inc.
403350
In Commercial Distribution

  • 00851977007642 ()
403350

  • Orthopaedic surgical procedure kit, non-medicated, reusable

Revolution External Plating System - 00854641008112

Slotted 90° Tubular Wrench x 10mm
Metalogix
900104
In Commercial Distribution

  • 00854641008112 ()

  • Slotted 90°
  • Diameter: 10mm
  • Length: 3.89 Inch


  • External orthopaedic fixation system, reusable

Revolution External Plating System - 00854641008099

General Tray
Metalogix
900127-F
In Commercial Distribution

  • 00854641008099 ()

  • Height: 10.1 Inch
  • Length: 20.9 Inch
  • Width: 10.3 Inch


  • External orthopaedic fixation system, reusable

Revolution External Plating System - 00854641008082

Instrument + Hardware Tray
Metalogix
900126-F
In Commercial Distribution

  • 00854641008082 ()

  • Height: 5.5 Inch
  • Length: 20.9 Inch
  • Width: 10.3 Inch


  • External orthopaedic fixation system, reusable

Revolution External Plating System - 00854641008075

J/N-Plate Tray
Metalogix
900125-F
In Commercial Distribution

  • 00854641008075 ()

  • Height: 9.6 Inch
  • Length: 20.9 Inch
  • Width: 10.3 Inch


  • External orthopaedic fixation system, reusable

Revolution External Plating System - 00854641008068

C/Footplate Tray
Metalogix
900124-F
In Commercial Distribution

  • 00854641008068 ()

  • Height: 10.1 Inch
  • Width: 10.3 Inch
  • Length: 20.9 Inch


  • External orthopaedic fixation system, reusable
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