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

  • 00613994839138 ()


  • Orthopaedic implant driver
DRIVER EX0411334 6.35 PROV. T-HANDLE
MEDTRONIC SOFAMOR DANEK, INC.
EX0411334
In Commercial Distribution

  • 00613994997487 ()


  • Orthopaedic implant driver
HEX DRIVER, 3.5mm
Pioneer Surgical Technology, Inc.
405-696
Not in Commercial Distribution

  • 00846468041045 ()
405-696

  • General internal orthopaedic fixation system implantation kit
Torque Driver
Pioneer Surgical Technology, Inc.
400-908
Not in Commercial Distribution

  • 00846468040932 ()


  • Internal spinal fixation system cable
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
5mm Hex Set Screw Driver(self-retaining)
BAUI BIOTECH CO. LTD.
409-0829
In Commercial Distribution

  • 04715862873629 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Poly Axial Screw Driver
BAUI BIOTECH CO. LTD.
409-0824
In Commercial Distribution

  • 04715862873575 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Mono Axial Screw Driver
BAUI BIOTECH CO. LTD.
409-0823
In Commercial Distribution

  • 04715862873568 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Poly Axial Screw Adjustable Driver
BAUI BIOTECH CO. LTD.
409-0813
In Commercial Distribution

  • 04715862873537 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
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