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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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Medtronic Reusable Instruments - 00613994846129

NUT DRIVER EX0610088 TORQUE LIMITING
MEDTRONIC SOFAMOR DANEK, INC.
EX0610088
In Commercial Distribution

  • 00613994846129 ()


  • Orthopaedic implant driver

Medtronic Reusable Instruments - 00613994839138

DRIVER EX0610183 3.5MM CAPTIVE TWIST HEX
MEDTRONIC SOFAMOR DANEK, INC.
EX0610183
In Commercial Distribution

  • 00613994839138 ()


  • Orthopaedic implant driver

Elemax® PLIF - 00846468066505

Inserter Fork, Large
Pioneer Surgical Technology, Inc.
32-EL-INSRTFORK-LG
Not in Commercial Distribution

  • 00846468066505 ()


  • General internal orthopaedic fixation system implantation kit

Elemax® PLIF - 00846468066482

Inserter Fork, Small
Pioneer Surgical Technology, Inc.
32-EL-INSRTFORK, SM
Not in Commercial Distribution

  • 00846468066482 ()


  • General internal orthopaedic fixation system implantation kit

Tritium® Sternal Cable Plate System - 00846468064181

Re-Entry Driver
Pioneer Surgical Technology, Inc.
86-RE-ENTRYDRV
Not in Commercial Distribution

  • 00846468064181 ()
86-RE-ENTRYDRV

  • Sternal fixation device

Elemax® Cortical Cancellous Spacer - 00846468062705

Inserter Shaft
Pioneer Surgical Technology, Inc.
30-CC-INSRTSHAFT
Not in Commercial Distribution

  • 00846468062705 ()


  • General internal orthopaedic fixation system implantation kit

Slimfuse® Anterior Cervical Plate System - 00846468062682

Final Driver, Extended
Pioneer Surgical Technology, Inc.
21-EXTDFINALDRV-TL
Not in Commercial Distribution

  • 00846468062682 ()
21-EXTDFINALDRV-TL

  • Orthopaedic inorganic implant inserter/extractor, reusable

Unison®-C Anterior Cervical Fixation System - 00846468081133

Angled Screw Driver Bit
Pioneer Surgical Technology, Inc.
64-ANG-SCREWDRIVER
Not in Commercial Distribution

  • 00846468081133 ()
64-ANG-SCREWDRIVER

  • General internal orthopaedic fixation system implantation kit

Unison®-C Anterior Cervical Fixation System - 00846468081010

Screw Driver, Locking
Pioneer Surgical Technology, Inc.
64-SCREWDRIVER-LKG
Not in Commercial Distribution

  • 00846468081010 ()
64-SCREWDRIVER-LKG

  • General internal orthopaedic fixation system implantation kit

Unison®-C Anterior Cervical Fixation System - 00846468081003

Screw Driver, Stab and Grab
Pioneer Surgical Technology, Inc.
64-SCREWDRIVER-SG
Not in Commercial Distribution

  • 00846468081003 ()
64-SCREWDRIVER-SG

  • General internal orthopaedic fixation system implantation kit
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