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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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Comet Lumbar Implant Driver
BAUI BIOTECH CO. LTD.
420-1724
In Commercial Distribution

  • 04718005159871 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
3mm Hex Screw Driver
BAUI BIOTECH CO. LTD.
406-0830A
In Commercial Distribution

  • 04718005155231 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
DRIVER, X-LINK®
Pioneer Surgical Technology, Inc.
10-XLINKDRIVER
Not in Commercial Distribution

  • 00846468022297 ()


  • General internal orthopaedic fixation system implantation kit
DRIVER, TORQUE LIMITING
Pioneer Surgical Technology, Inc.
10-TLHANDLE
Not in Commercial Distribution

  • 00846468022181 ()


  • General internal orthopaedic fixation system implantation kit
DRIVER, ROD TO ROD
Pioneer Surgical Technology, Inc.
10-RDDRIVER
Not in Commercial Distribution

  • 00846468021610 ()


  • General internal orthopaedic fixation system implantation kit
FINAL DRIVER
Pioneer Surgical Technology, Inc.
10-FINALDRIVER
Not in Commercial Distribution

  • 00846468020637 ()


  • General internal orthopaedic fixation system implantation kit
FINAL DRIVER
Pioneer Surgical Technology, Inc.
05-FINALDRIVER
Not in Commercial Distribution

  • 00846468050658 ()
05-FINALDRIVER

  • General internal orthopaedic fixation system implantation kit
Disposable Torque-Limiting Final Driver
Pioneer Surgical Technology, Inc.
21-SU-TLFNLDRV-S
Not in Commercial Distribution

  • 00846468050580 ()


  • Orthopaedic prosthesis implantation positioning instrument, single-use
DRIVER 2342280L 4.75 FAS L
MEDTRONIC SOFAMOR DANEK, INC.
2342280L
In Commercial Distribution

  • 00613994649751 ()


  • Bone tap, reusable
DRIVER 2342280S 4.75 FAS S
MEDTRONIC SOFAMOR DANEK, INC.
2342280S
In Commercial Distribution

  • 00613994649737 ()


  • Bone tap, reusable
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