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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DRIVER X0805149 5.5 W/O CROSSBAR 165MM
MEDTRONIC SOFAMOR DANEK, INC.
X0805149
In Commercial Distribution

  • 00613994317872 ()


  • Surgical screwdriver, reusable
TOOL 1201111 STND ALONE REV PEEK PREVAIL
MEDTRONIC SOFAMOR DANEK, INC.
1201111
In Commercial Distribution

  • 00613994309495 ()


  • Surgical screwdriver, reusable
DRIVER 8675203 5MM HEX
MEDTRONIC SOFAMOR DANEK, INC.
8675203
In Commercial Distribution

  • 00613994306265 ()


  • Surgical screwdriver, reusable
DRIVER 8675207 LONG
MEDTRONIC SOFAMOR DANEK, INC.
8675207
In Commercial Distribution

  • 00613994306227 ()


  • Surgical screwdriver, reusable
CREWDRIVER 7756187 STRAIGHT HEX
MEDTRONIC SOFAMOR DANEK, INC.
7756187
In Commercial Distribution

  • 00613994305862 ()

  • 2.5mm


  • Surgical screwdriver, reusable
DRIVER 7650091 S SCREW RETAINING
MEDTRONIC SOFAMOR DANEK, INC.
7650091
In Commercial Distribution

  • 00613994302816 ()


  • Surgical screwdriver, reusable
SCREWDRIVER 7570907 NR FANGLE
MEDTRONIC SOFAMOR DANEK, INC.
7570907
In Commercial Distribution

  • 00613994302809 ()


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

  • 00613994290250 ()


  • Surgical mallet
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
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
DRIVER 6480144 7 32 INCH BREAKOFF
MEDTRONIC SOFAMOR DANEK, INC.
6480144
In Commercial Distribution

  • 00613994331243 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
SCREWDRIVER 6480282 FIXED ANGLE
MEDTRONIC SOFAMOR DANEK, INC.
6480282
In Commercial Distribution

  • 00613994331205 ()


  • Surgical screwdriver, reusable
SCREWDRIVER 7756188 RIGHT ANGLE 2.5 HEX
MEDTRONIC SOFAMOR DANEK, INC.
7756188
In Commercial Distribution

  • 00613994330253 ()

  • 2.5mm


  • Surgical screwdriver, reusable
EXTENDER 8350110 SCREW 120MM
MEDTRONIC SOFAMOR DANEK, INC.
8350110
In Commercial Distribution

  • 00613994326027 ()

  • 3.2mm HEX


  • Surgical screwdriver, reusable
STANDARD ABUTMENT DRIVER 24MM(L)
BIOMET 3I, LLC
PAD24
In Commercial Distribution

  • 00844868013686 ()

  • Length: 24 Millimeter


  • Surgical screwdriver, reusable
DAL-RO ABUTMENT DRIVER
BIOMET 3I, LLC
PAD03
In Commercial Distribution

  • 00844868013679 ()


  • Surgical screwdriver, reusable
O-RING/DALRO ABUTMENT DRIVER
BIOMET 3I, LLC
PAD01
In Commercial Distribution

  • 00844868013662 ()


  • Surgical screwdriver, reusable
POSTERIOR ABUTMENT DRIVER 17MM
BIOMET 3I, LLC
PAD00
In Commercial Distribution

  • 00844868013655 ()

  • Length: 17 Millimeter


  • Surgical screwdriver, reusable
NAVIGATOR® CERTAIN® IMPLANT MOUNT, 3.4MM(D) X 4(L)
BIOMET 3I, LLC
MSGIIM4
In Commercial Distribution

  • 00844868010524 ()

  • Diameter 3.4 mm
  • Length: 4 Millimeter


  • Surgical screwdriver, reusable
NAVIGATOR® CERTAIN® IMPLANT MOUNT, 3.4MM(D) X 3(L)
BIOMET 3I, LLC
MSGIIM3
In Commercial Distribution

  • 00844868010517 ()

  • Length: 3 Millimeter
  • Diameter 3.4 mm


  • Surgical screwdriver, reusable
NAVIGATOR® CERTAIN® IMPLANT MOUNT, 3.4MM(D) X 2(L)
BIOMET 3I, LLC
MSGIIM2
In Commercial Distribution

  • 00844868010500 ()

  • Diameter 3.4 mm
  • Length: 2 Millimeter


  • Surgical screwdriver, reusable
NAVIGATOR® CERTAIN® IMPLANT MOUNT, 3.4MM(D) X 1(L)
BIOMET 3I, LLC
MSGIIM1
In Commercial Distribution

  • 00844868010494 ()

  • Length: 1 Millimeter
  • Diameter 3.4 mm


  • Surgical screwdriver, reusable
IMPLANT MOUNT KIT 3.4MM(D)
BIOMET 3I, LLC
MMKIT
Not in Commercial Distribution

  • 00844868010340 ()

  • Diameter 3.4 mm


  • Surgical screwdriver, reusable
IMPLANT MOUNT 3.4MM(D) X 15MM(L)
BIOMET 3I, LLC
MMC15
In Commercial Distribution

  • 00844868010302 ()

  • Length: 15 Millimeter
  • Diameter 3.4 mm


  • Surgical screwdriver, reusable
IMPLANT MOUNT 3.4MM(D) X 3MM(L)
BIOMET 3I, LLC
MMC03
In Commercial Distribution

  • 00844868010296 ()

  • Length: 3 Millimeter
  • Diameter 3.4 mm


  • Surgical screwdriver, reusable
MANUAL INTERCHANGEABLE DRIVER TIP HANDLE
BIOMET 3I, LLC
MIDTH
In Commercial Distribution

  • 00844868010203 ()


  • Surgical screwdriver, reusable
TG RATCHET ADAPTER
BIOMET 3I, LLC
MDR10H
Not in Commercial Distribution

  • 00844868010098 ()


  • Surgical screwdriver, reusable
HANDPIECE CONNECTOR
BIOMET 3I, LLC
MDR10
In Commercial Distribution

  • 00844868010081 ()


  • Surgical screwdriver, reusable
MALLET, STAINLESS STEEL
BIOMET 3I, LLC
MALL1
Not in Commercial Distribution

  • 00844868009962 ()


  • Surgical mallet
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