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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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Mimics Enlight CMF Orthognathic Planner
Materialise NV
Orthognathic Planner
In Commercial Distribution

  • 05404028000809 ()
Orthognathic Planner

  • CAD/CAM software
DRIVER NAV2081K VERT THREADED
MEDTRONIC SOFAMOR DANEK, INC.
NAV2081K
In Commercial Distribution

  • 00643169672857 ()


  • Surgical screwdriver, reusable
Threaded Driver
DUNAMIS MEDICAL, LLC
1001610
In Commercial Distribution

  • 00850052601157 ()
1001610

  • Orthopaedic fixation suture button
TORQUE DRIVER
PMT CORPORATION
1201-8
In Commercial Distribution

  • 00650551044949 ()
1201-8

  • Cervical spine immobilization system, single-use
PRECISION TORQUE DRIVER
PMT CORPORATION
1201-7
In Commercial Distribution

  • 00650551044932 ()
1201-7

  • Cervical spine immobilization system, single-use
DOUBLE ENDED TORQUE DRIVER BIT, FOR 1201-8 TORQUE WRENCH
PMT CORPORATION
1201-52
In Commercial Distribution

  • 00650551044918 ()
1201-52

  • Cervical spine immobilization system, single-use
BALL ENDED TORQUE DRIVER BIT, FOR 1201-7 PRECISION TORQUE DRIVER
PMT CORPORATION
1201-44
In Commercial Distribution

  • 00650551044864 ()
1201-44

  • Cervical spine immobilization system, single-use
DISPOSABLE TORQUE DRIVER
PMT CORPORATION
1201-25
In Commercial Distribution

  • 00650551044819 ()
1201-25

  • Cervical spine immobilization system, single-use
aprevo® Angled Driver
Carlsmed, Inc.
1540
In Commercial Distribution

  • 00810056993030 ()


  • Orthopaedic inorganic implant inserter/extractor, single-use
aprevo® Straight Driver
Carlsmed, Inc.
1520
In Commercial Distribution

  • 00810056993016 ()


  • Orthopaedic inorganic implant inserter/extractor, single-use
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