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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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Instrument, Expansion Screwdriver, Long
SPINESOURCE INC
097
In Commercial Distribution

  • 00850011324097 ()
SD-4100

  • Surgical screwdriver, reusable
SF M6 Bolt Driver
Clearpoint Neuro, Inc.
NGS-BD-M6
In Commercial Distribution

  • 00850359007584 ()
NGS-BD-M6

  • Neurological stereotactic surgery system
Auxiliary Driver
SAIL FUSION, LLC
90-JFB-301100
In Commercial Distribution

  • 00850053568510 ()


  • Sacroiliac joint transarticular fixation/arthrodesis implantation kit
Square Cage Driver (AO connector)
CAPTIVA SPINE, INC.
CSE06-R-0500-86
In Commercial Distribution

  • 00850065741253 ()


  • Surgical implant/trial-implant/sizer holder, reusable
  • Orthopaedic implant driver
Slap Hammer (tuning fork style)
CAPTIVA SPINE, INC.
CSE06-R-1000-29
In Commercial Distribution

  • 00850065741239 ()


  • Surgical mallet
Hammer power shaft
CAPTIVA SPINE, INC.
CSE06-R-0500-26
In Commercial Distribution

  • 00850065741055 ()


  • Surgical mallet
Hammer connecting shaft
CAPTIVA SPINE, INC.
CSE06-R-0500-28
In Commercial Distribution

  • 00850065741048 ()


  • Surgical mallet
Square Cage Driver
CAPTIVA SPINE, INC.
CSE06-R-0500-48
In Commercial Distribution

  • 00850065741031 ()


  • Surgical implant/trial-implant/sizer holder, reusable
  • Orthopaedic implant driver
Needle Driver
MEDROBOTICS CORPORATION
50474
In Commercial Distribution

  • 00850190004674 ()


  • Laparoscopic blunt dissector
The CrossRoads Screw System is indicated for fracture repair and fixation, osteotomy, joint fusion, reconstruction and arthrodesis of bones appropriate for the size of the device.
CROSSROADS EXTREMITY SYSTEMS
6.5 Headed Implant Prep Kit Including Reamer
In Commercial Distribution

  • 00850310006892 ()
1456-6565

  • Surgical countersink, single-use
  • Surgical instrument handle, non-torque-limiting
  • Fluted surgical drill bit, single-use
  • Surgical screwdriver, single-use
  • Surgical depth gauge, single-use
  • Orthopaedic intraoperative positioning pin, single-use
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