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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
CUSMED CirFIX® Burr Hole Cover, Radiolucent Revisable Type for Shunt & ICP+Screwdriver, PEEK, 14mm/11mm, Sterile
OSSAWARE BIOTECH CO., LTD.
9906.0014.11S
In Commercial Distribution

  • 04717002404335 ()
  • 14717002404332 ()
  • 24717002404339 ()
9906.0014.11S

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
CUSMED CirFIX® Burr Hole Cover, Radiolucent Revisable Type+Screwdriver, PEEK, 14mm/11mm, Sterile
OSSAWARE BIOTECH CO., LTD.
9905.0014.11S
In Commercial Distribution

  • 14717002404325 ()
  • 04717002404328 ()
  • 24717002404322 ()
9905.0014.11S

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
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
Modular Screw Driver Shaft I w/AO Fitting
Pioneer Surgical Technology, Inc.
0259-0001
Not in Commercial Distribution

  • 00846468018535 ()
0259-0001

  • Spinal fixation plate, non-bioabsorbable
DRIVER EX0111002 T27
MEDTRONIC SOFAMOR DANEK, INC.
EX0111002
In Commercial Distribution

  • 00613994947932 ()


  • Surgical drill guide, reusable
DRIVER 5484339 DUAL PURPOSE DRIVER
MEDTRONIC SOFAMOR DANEK, INC.
5484339
In Commercial Distribution

  • 00613994946652 ()


  • Orthopaedic implant driver
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