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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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TRAUMA KIT, 1211-1M MEDIUM RING, 1206-33 HEADBLOCK, 1206-11 TRACTION BAIL, 1201-8 TORQUE DRIVER
PMT CORPORATION
1211-6M4
In Commercial Distribution

  • 00650551094555 ()
1211-6M4

  • Cervical spine immobilization system, single-use
TRAUMA KIT, 1211-1M MEDIUM RING, 1206-32 HEADBLOCK, 1206-11 TRACTION BAIL, 1201-8 TORQUE DRIVER
PMT CORPORATION
1211-6M3
In Commercial Distribution

  • 00650551094548 ()
1211-6M3

  • Cervical spine immobilization system, single-use
TRAUMA KIT, 1211-1M MEDIUM RING, 1206-20 HEADBLOCK, 1206-11 TRACTION BAIL, 1201-8 TORQUE DRIVER
PMT CORPORATION
1211-6M1
In Commercial Distribution

  • 00650551094531 ()
1211-6M1

  • Cervical spine immobilization system, single-use
TRAUMA KIT, 1211-1L LARGE RING, 1206-33 HEADBLOCK, 1206-11 TRACTION BAIL, 1201-8 TORQUE DRIVER
PMT CORPORATION
1211-6L4
In Commercial Distribution

  • 00650551094524 ()
1211-6L4

  • Cervical spine immobilization system, single-use
TRAUMA KIT, 1211-1L LARGE RING, 1206-32 HEADBLOCK, 1206-11 TRACTION BAIL, 1201-8 TORQUE DRIVER
PMT CORPORATION
1211-6L3
In Commercial Distribution

  • 00650551094517 ()
1211-6L3

  • Cervical spine immobilization system, single-use
TRAUMA KIT, 1211-1L LARGE RING, 1206-20 HEADBLOCK, 1206-11 TRACTION BAIL, 1201-8 TORQUE DRIVER
PMT CORPORATION
1211-6L1
In Commercial Distribution

  • 00650551094500 ()
1211-6L1

  • Cervical spine immobilization system, single-use
SAM IO Driver
ZIEN MEDICAL TECHNOLOGIES, INC.
IO700
In Commercial Distribution

  • 10850068519030 ()
  • 00850068519033 ()


  • Intraosseous-access handpiece, infusion, manual
FORWARD IO Infusion Kit with SAM IO Adaptor, SAM IO Driver, SAM IO 25mm Needle Assembly and SAM IO 45mm Assembly.
INTEGRATED MEDCRAFT LLC
1011-23000CB
In Commercial Distribution

  • 00850056748018 ()


  • Intraosseous infusion kit
SF M6 Bolt Driver
Clearpoint Neuro, Inc.
NGS-BD-M6
In Commercial Distribution

  • 00850359007584 ()
NGS-BD-M6

  • Neurological stereotactic surgery system
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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