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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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Sequential Distractor, 8mm
MEDTRONIC SOFAMOR DANEK, INC.
2307-9008
In Commercial Distribution

  • 00191375002017 ()

  • Height: 8 Millimeter


  • Bone lever/elevator, reusable
Reverse Thread Extractor
MEDTRONIC SOFAMOR DANEK, INC.
2300-1102
In Commercial Distribution

  • 00191375002000 ()

  • Length: 12.5 Inch


  • Orthopaedic inorganic implant inserter/extractor, reusable
Locking Implant Holder
MEDTRONIC SOFAMOR DANEK, INC.
2300-1015
In Commercial Distribution

  • 00191375001997 ()

  • Length: 15 Inch


  • Orthopaedic inorganic implant inserter/extractor, reusable
Implant Remover
MEDTRONIC SOFAMOR DANEK, INC.
2300-1012
In Commercial Distribution

  • 00191375001980 ()

  • Length: 12 Inch


  • Orthopaedic inorganic implant inserter/extractor, reusable
Hex Swivel Screwdriver
MEDTRONIC SOFAMOR DANEK, INC.
2300-1302
In Commercial Distribution

  • 00191375001973 ()

  • Length: 11 Inch


  • Surgical instrument handle, non-torque-limiting
Hex Straight Screwdriver
MEDTRONIC SOFAMOR DANEK, INC.
2300-1301
In Commercial Distribution

  • 00191375001966 ()

  • Length: 9.5 Inch


  • Surgical instrument handle, non-torque-limiting
Curved, Fixed Handle Awl
MEDTRONIC SOFAMOR DANEK, INC.
2300-1120
In Commercial Distribution

  • 00191375001959 ()

  • Length: 15 Inch


  • Bone awl, reusable
Straight, Fixed Handle Awl
MEDTRONIC SOFAMOR DANEK, INC.
2300-1110
In Commercial Distribution

  • 00191375001942 ()

  • Length: 15 Inch


  • Bone awl, reusable
Screwdriver Ratcheting 14in SQ QLOK Adaptor
MEDTRONIC SOFAMOR DANEK, INC.
2300-1046
In Commercial Distribution

  • 00191375001935 ()

  • Length: 6 Inch


  • Surgical instrument handle, non-torque-limiting
.25 in Sq Non-Ratchet Screwdriver, T-Handle
MEDTRONIC SOFAMOR DANEK, INC.
2300-1039
In Commercial Distribution

  • 00191375001928 ()

  • Width: 3 Inch
  • Width: 4 Inch


  • Surgical instrument handle, non-torque-limiting
Awl Guide
MEDTRONIC SOFAMOR DANEK, INC.
2300-1036
In Commercial Distribution

  • 00191375001904 ()

  • Length: 11 Inch


  • Orthopaedic implantation sleeve, reusable
Implant Case
TITAN SPINE, LLC
2106-1009
Not in Commercial Distribution

  • 00191375001256 ()

  • Length: 20 Inch
  • Width: 10 Inch
  • Height: 2 Inch
2106-1009

  • Instrument tray, reusable
Implant Tray with Caddies
TITAN SPINE, LLC
2106-1014
Not in Commercial Distribution

  • 00191375001249 ()

  • Length: 21 Inch
  • Width: 10 Inch
  • Height: 3 Inch
2106-1014

  • Instrument tray, reusable
Instrument Case
TITAN SPINE, LLC
2106-1010
Not in Commercial Distribution

  • 00191375001232 ()

  • Height: 4 Inch
  • Length: 20 Inch
  • Width: 10 Inch
2106-1010

  • Instrument tray, reusable
12 Deg Lordotic, Rasp, X-Large, 16mm
MEDTRONIC SOFAMOR DANEK, INC.
2112-7316
In Commercial Distribution

  • 00191375001225 ()

  • Angle: 12 degree
  • Width: 40 Millimeter
  • Depth: 27 Millimeter
  • width(MLxAP), 40 x 27, mm
  • Height: 16 Millimeter
  • Lordotic Angle 12 Deg


  • Bone file/rasp, manual, reusable
12 Deg Lordotic, Rasp, X-Large, 15mm
MEDTRONIC SOFAMOR DANEK, INC.
2112-7315
In Commercial Distribution

  • 00191375001218 ()

  • Angle: 12 degree
  • Depth: 27 Millimeter
  • Width: 40 Millimeter
  • width(MLxAP), 40 x 27, mm
  • Height: 15 Millimeter
  • Lordotic Angle 12 Deg


  • Bone file/rasp, manual, reusable
12 Deg Lordotic, Rasp, X-Large, 14mm
MEDTRONIC SOFAMOR DANEK, INC.
2112-7314
In Commercial Distribution

  • 00191375001201 ()

  • Angle: 12 degree
  • Width: 40 Millimeter
  • Depth: 27 Millimeter
  • width(MLxAP), 40 x 27, mm
  • Lordotic Angle 12 Deg
  • Height: 14 Millimeter


  • Bone file/rasp, manual, reusable
12 Deg Lordotic, Rasp, X-Large, 13mm
MEDTRONIC SOFAMOR DANEK, INC.
2112-7313
In Commercial Distribution

  • 00191375001195 ()

  • width(MLxAP), 40 x 27, mm
  • Depth: 27 Millimeter
  • Width: 40 Millimeter
  • Angle: 12 degree
  • Lordotic Angle 12 Deg
  • Height: 13 Millimeter


  • Bone file/rasp, manual, reusable
12 Deg Lordotic, Rasp, X-Large, 12mm
MEDTRONIC SOFAMOR DANEK, INC.
2112-7312
In Commercial Distribution

  • 00191375001188 ()

  • Depth: 27 Millimeter
  • width(MLxAP), 40 x 27, mm
  • Width: 40 Millimeter
  • Angle: 12 degree
  • Height: 12 Millimeter
  • Lordotic Angle 12 Deg


  • Bone file/rasp, manual, reusable
12 Deg Lordotic, Rasp, X-Large, 11mm
MEDTRONIC SOFAMOR DANEK, INC.
2112-7311
In Commercial Distribution

  • 00191375001171 ()

  • Angle: 12 degree
  • width(MLxAP), 40 x 27, mm
  • Width: 40 Millimeter
  • Depth: 27 Millimeter
  • Height: 11 Millimeter
  • Lordotic Angle 12 Deg


  • Bone file/rasp, manual, reusable
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