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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IMPLANT CARRIER 15MM
BIOMET 3I, LLC
IC015
In Commercial Distribution

  • 00844868004219 ()

  • Length: 15 Millimeter


  • Surgical screwdriver, reusable
HAMMER X3986522 SLAP
MEDTRONIC SOFAMOR DANEK, INC.
X3986522
Not in Commercial Distribution

  • 00613994290250 ()


  • Surgical mallet
ADAPTOR X1106093 TRI FLAT QUICK CONNECT
MEDTRONIC SOFAMOR DANEK, INC.
X1106093
In Commercial Distribution

  • 00613994289285 ()


  • Surgical screwdriver, reusable
DRIVER 9870010 FLEXIBLE HEX 3.2MM
MEDTRONIC SOFAMOR DANEK, INC.
9870010
In Commercial Distribution

  • 00613994284952 ()

  • 3.2mm HEX


  • Surgical screwdriver, reusable
DRIVER 9870011 SCREW 3.2MM TAPER HEX
MEDTRONIC SOFAMOR DANEK, INC.
9870011
In Commercial Distribution

  • 00613994284945 ()

  • 3.2mm


  • Surgical screwdriver, reusable
DRIVER 9870012 SCREW 3.2MM STRAIGHT HEX
MEDTRONIC SOFAMOR DANEK, INC.
9870012
In Commercial Distribution

  • 00613994284938 ()

  • 3.2mm


  • Surgical screwdriver, reusable
AWL 9870013 TACK PIN
MEDTRONIC SOFAMOR DANEK, INC.
9870013
In Commercial Distribution

  • 00613994284921 ()


  • Surgical screwdriver, reusable
DRIVER 9870014 TEMPORARY AWL TACK
MEDTRONIC SOFAMOR DANEK, INC.
9870014
In Commercial Distribution

  • 00613994284792 ()


  • Bone awl, reusable
PANEL 016-200 CRANIAL MESH 200 X 200MM
MEDTRONIC PS MEDICAL, INC.
016-200
In Commercial Distribution

  • 00613994284655 ()

  • Width: 200.0 Millimeter
  • Length: 200.0 Millimeter
  • Height: 0.6 Millimeter


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
PANEL 016-152 CRANIAL MESH 152 X 152MM
MEDTRONIC PS MEDICAL, INC.
016-152
In Commercial Distribution

  • 00613994284648 ()

  • Length: 152.0 Millimeter
  • Height: 0.6 Millimeter
  • Width: 152.0 Millimeter


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
PANEL 016-128 CRANIAL MESH 128 X 79MM
MEDTRONIC PS MEDICAL, INC.
016-128
In Commercial Distribution

  • 00613994284631 ()

  • Length: 128.0 Millimeter
  • Width: 79.0 Millimeter
  • Height: 0.6 Millimeter


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
PANEL 016-120 CRANIAL MESH 120 X 120MM
MEDTRONIC PS MEDICAL, INC.
016-120
In Commercial Distribution

  • 00613994284624 ()

  • Width: 120.0 Millimeter
  • Length: 120.0 Millimeter
  • Height: 0.6 Millimeter


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
PANEL 016-100 CRANIAL MESH 100 X 100MM
MEDTRONIC PS MEDICAL, INC.
016-100
In Commercial Distribution

  • 00613994284617 ()

  • Length: 100.0 Millimeter
  • Width: 100.0 Millimeter
  • Height: 0.6 Millimeter


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
MESH CMESH-1WK CUSTOM 1WK IMPLANT
MEDTRONIC PS MEDICAL, INC.
CMESH-1WK
In Commercial Distribution

  • 00613994284600 ()


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
MESH CMESH-2WK CUSTOM 2WK IMPLANT
MEDTRONIC PS MEDICAL, INC.
CMESH-2WK
In Commercial Distribution

  • 00613994284594 ()


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
MESH CMESH-3WK CUSTOM 3WK IMPLANT
MEDTRONIC PS MEDICAL, INC.
CMESH-3WK
In Commercial Distribution

  • 00613994284587 ()


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
DRIVER 8350316 SET SCREW 6.35 HEX
MEDTRONIC SOFAMOR DANEK, INC.
8350316
In Commercial Distribution

  • 00613994282873 ()

  • 6.35mm HEX


  • Surgical screwdriver, reusable
SCREWDRIVER 8350325 MPA
MEDTRONIC SOFAMOR DANEK, INC.
8350325
In Commercial Distribution

  • 00613994282712 ()


  • Surgical screwdriver, reusable
DRIVER 8350304 SCREW
MEDTRONIC SOFAMOR DANEK, INC.
8350304
In Commercial Distribution

  • 00613994282569 ()

  • 3.2mm HEX


  • Surgical screwdriver, reusable
DRIVER 8350305 SCREW ADJUSTMENT
MEDTRONIC SOFAMOR DANEK, INC.
8350305
In Commercial Distribution

  • 00613994282552 ()


  • Orthopaedic implant driver
DRIVER 8350344 REDUCTION PROVISIONAL
MEDTRONIC SOFAMOR DANEK, INC.
8350344
In Commercial Distribution

  • 00613994282521 ()


  • Instrument tray, reusable
SCREWDRIVER 8350326 RIGID REDUCTION
MEDTRONIC SOFAMOR DANEK, INC.
8350326
In Commercial Distribution

  • 00613994282347 ()

  • 3.5 HEX


  • Surgical screwdriver, reusable
DRIVER 8350328 QUICK THREAD
MEDTRONIC SOFAMOR DANEK, INC.
8350328
In Commercial Distribution

  • 00613994282323 ()


  • Surgical screwdriver, reusable
BENDER 8350338 INSITU LEFT
MEDTRONIC SOFAMOR DANEK, INC.
8350338
In Commercial Distribution

  • 00613994282224 ()


  • Surgical screwdriver, reusable
BENDER 8350339 INSITU RIGHT
MEDTRONIC SOFAMOR DANEK, INC.
8350339
In Commercial Distribution

  • 00613994282217 ()


  • Surgical screwdriver, reusable
SCREWDRIVER X0906063 LOCK SCREWDRIVER
MEDTRONIC SOFAMOR DANEK, INC.
X0906063
In Commercial Distribution

  • 00613994265746 ()


  • Surgical screwdriver, reusable
SCREWDRIVER X0806301 MULTI-AXIAL-5.5
MEDTRONIC SOFAMOR DANEK, INC.
X0806301
Not in Commercial Distribution

  • 00613994265425 ()


  • Surgical screwdriver, reusable
SCREWDRIVER X0806300 FIXED ANGLE-5.5
MEDTRONIC SOFAMOR DANEK, INC.
X0806300
Not in Commercial Distribution

  • 00613994265418 ()


  • Surgical screwdriver, reusable
PIN DRIVER 6474630
MEDTRONIC SOFAMOR DANEK, INC.
6474630
In Commercial Distribution

  • 00613994363886 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
HANDLE X0906049 RATCHETING T QUICK CONN
MEDTRONIC SOFAMOR DANEK, INC.
X0906049
Not in Commercial Distribution

  • 00613994270832 ()


  • Surgical screwdriver, reusable
THORACIC POLYAXIAL SCREWDRIVER
ALPHATEC SPINE, INC.
63953
In Commercial Distribution

  • 00844856053045 ()


  • Surgical screwdriver, reusable
PARALLEL SCREWDRIVER
ALPHATEC SPINE, INC.
61736R
In Commercial Distribution

  • 00844856052789 ()


  • Surgical screwdriver, reusable
ROD CONNECTOR DRIVER
ALPHATEC SPINE, INC.
63949-R
In Commercial Distribution

  • 00844856051980 ()


  • Surgical screwdriver, reusable
OSSEOSCREW POLYAXIAL/HIGH TOP DRIVER
ALPHATEC SPINE, INC.
54900-03
Not in Commercial Distribution

  • 00844856051683 ()


  • Surgical screwdriver, reusable
OSSEOSCREW RETRIEVAL TOOL
ALPHATEC SPINE, INC.
54900-30
In Commercial Distribution

  • 00844856051584 ()


  • Surgical screwdriver, reusable
ILIAC SCREW DRIVER, 30°
ALPHATEC SPINE, INC.
92930-30
In Commercial Distribution

  • 00844856045750 ()


  • Surgical screwdriver, reusable
ILIAC SCREW DRIVER, 15°
ALPHATEC SPINE, INC.
92930-15
In Commercial Distribution

  • 00844856045743 ()


  • Surgical screwdriver, reusable
HEXALOBE SET SCREW DRIVER SHAFT
ALPHATEC SPINE, INC.
92939
In Commercial Distribution

  • 00844856044357 ()


  • Surgical screwdriver, reusable
MALLET
ALPHATEC SPINE, INC.
73702
In Commercial Distribution

  • 00844856043923 ()


  • Surgical mallet
Set Screw Driver
ALPHATEC SPINE, INC.
92938-HL
In Commercial Distribution

  • 00844856036406 ()


  • Surgical screwdriver, reusable
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