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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Locking Screw Inserter, Short
K2M, INC.
PRO-1186-01
In Commercial Distribution

  • 10888857550278 ()
PRO-1186-01

  • Surgical screwdriver, reusable
Polyaxial Screwdriver, Locking
K2M, INC.
PRO-1154
In Commercial Distribution

  • 10888857549869 ()
PRO-1154

  • Surgical screwdriver, reusable
Screw Driver w/ Thread
K2M, INC.
PRO-1156
In Commercial Distribution

  • 10888857548602 ()
PRO-1156

  • Orthopaedic prosthesis implantation positioning instrument, reusable
DRIVER X0514009 T27 QUICK CONNECT
MEDTRONIC SOFAMOR DANEK, INC.
X0514009
In Commercial Distribution

  • 00643169496569 ()


  • Orthopaedic implant driver
DRIVER X0214111 BREAKOFF
MEDTRONIC SOFAMOR DANEK, INC.
X0214111
In Commercial Distribution

  • 00643169496149 ()


  • Orthopaedic implant driver
90132 Neoss LOCATOR® Driver Machine, 23 mm
Neoss Ltd
90132
In Commercial Distribution

  • 05060440333248 ()
90132

  • Surgical screwdriver, reusable
90131 Neoss LOCATOR® Driver Manual, 15 mm
Neoss Ltd
90131
In Commercial Distribution

  • 05060440333231 ()
90131

  • Surgical screwdriver, reusable
Tack Mallet
Neoss AB
64033
In Commercial Distribution

  • 05060440332852 ()
64033

  • Surgical mallet
Neoss® Guide – Implant Mount SP, Ø6.0 S9 – 2 pcs
Neoss AB
51174
In Commercial Distribution

  • 05060440332821 ()
51174

  • Surgical screwdriver, reusable
Neoss® Guide – Implant Mount SP, Ø5.0 S9 – 2 pcs
Neoss AB
51173
In Commercial Distribution

  • 05060440332814 ()
51173

  • Surgical screwdriver, reusable
Neoss® Guide – Implant Inserter, SP
Neoss AB
51155
In Commercial Distribution

  • 05060440332692 ()
51155

  • Surgical screwdriver, reusable
Implant Inserter, NP 32 mm
Neoss AB
51142
In Commercial Distribution

  • 05060440332623 ()
51142

  • Surgical screwdriver, reusable
Neo Screwdriver, Machine 22mm
Neoss AB
51139
In Commercial Distribution

  • 05060440332593 ()
51139

  • Surgical screwdriver, reusable
Ball Driver
Neoss AB
51124
In Commercial Distribution

  • 05060440332548 ()
51124

  • Fixture/appliance dental drill bit, single-use
Implant Inserter, SP 32 mm
Neoss AB
51119
In Commercial Distribution

  • 05060440332524 ()
51119

  • Surgical screwdriver, reusable
Implant Inserter, SP 22 mm
Neoss AB
51118
In Commercial Distribution

  • 05060440332517 ()
51118

  • Surgical screwdriver, reusable
DRIVER X0114021 T27
MEDTRONIC SOFAMOR DANEK, INC.
X0114021
In Commercial Distribution

  • 00643169482227 ()


  • Surgical screwdriver, reusable
DRIVER EX0214133 T25 ATTACHMENT
MEDTRONIC SOFAMOR DANEK, INC.
EX0214133
In Commercial Distribution

  • 00643169477087 ()


  • Orthopaedic implant driver
DRIVER NAV2081 VERT THREADED
MEDTRONIC SOFAMOR DANEK, INC.
NAV2081
In Commercial Distribution

  • 00643169474895 ()


  • Surgical screwdriver, reusable
DRIVER X1013216 STEP 5.5/6.0 RMAS SOLID
MEDTRONIC SOFAMOR DANEK, INC.
X1013216
In Commercial Distribution

  • 00643169468771 ()

  • 5.5/6.0mm


  • Bone tap, reusable
DRIVER X1013213 STEP 5.5/6.0 MAS CANN
MEDTRONIC SOFAMOR DANEK, INC.
X1013213
In Commercial Distribution

  • 00643169468740 ()

  • 5.5/6.0mm


  • Bone/joint surgical power tool motorized handpiece/set, electric, reusable
DRIVER X1013212 STEP 5.5/6.0 MAS SOLID
MEDTRONIC SOFAMOR DANEK, INC.
X1013212
In Commercial Distribution

  • 00643169468733 ()

  • 5.5/6.0mm


  • Bone/joint surgical power tool motorized handpiece/set, electric, reusable
DRIVER X1013202 CANN RETAINING TWIST
MEDTRONIC SOFAMOR DANEK, INC.
X1013202
In Commercial Distribution

  • 00643169468634 ()


  • Bone/joint surgical power tool motorized handpiece/set, electric, reusable
Driver
K2M, INC.
PRO-1091-02
In Commercial Distribution

  • 10888857527713 ()
PRO-1091-02

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Cam Lock Driver
K2M, INC.
PRO-1418-09
In Commercial Distribution

  • 10888857588301 ()
PRO-1418-09

  • Surgical screwdriver, reusable
Locking Screw Inserter
K2M, INC.
PRO-1370
In Commercial Distribution

  • 10888857580374 ()
PRO-1370

  • Surgical screwdriver, reusable
Driver Shaft
K2M, INC.
PRO-1232-06
In Commercial Distribution

  • 10888857580213 ()
PRO-1232-06

  • Surgical screwdriver, reusable
Tapered Driver Size 10
K2M, INC.
PRO-1400
In Commercial Distribution

  • 10888857580176 ()
PRO-1400

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Forceps Rod Fork
K2M, INC.
PRO-1401
In Commercial Distribution

  • 10888857579897 ()
PRO-1401

  • Surgical screwdriver, reusable
Driver, Height Adjustment Size 25
K2M, INC.
PRO-1378
In Commercial Distribution

  • 10888857579637 ()
PRO-1378

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Screwdriver, Split Tip
K2M, INC.
PRO-1330
In Commercial Distribution

  • 10888857563254 ()
PRO-1330

  • Surgical screwdriver, reusable
Flex Shaft Tapered Driver Size 20
K2M, INC.
PRO-1218
In Commercial Distribution

  • 10888857561595 ()
PRO-1218

  • Surgical screwdriver, reusable
Self Retaining Screw Inserter
K2M, INC.
PRO-1318
In Commercial Distribution

  • 10888857561373 ()
PRO-1318

  • Orthopaedic implant driver
SAFIRA System hand operator for controlling SAFIRA Driver
MEDOVATE LIMITED
SAFIRA Palm Operator
In Commercial Distribution

  • 05060727270068 ()
900059

  • Pain management medication delivery system
SAFIRA Driver unit that injects/aspirates works in combination with SAFIRA operators and SAFIRA Syringes
MEDOVATE LIMITED
SAFIRA Driver
In Commercial Distribution

  • 05060727270020 ()
900029

  • Pain management medication delivery system
SAFIRA system foot operator for controlling SAFIRA Driver
MEDOVATE LIMITED
SAFIRA Foot Pedal
In Commercial Distribution

  • 05060727270013 ()
900044

  • Pain management medication delivery system
DRIVER 2300000LO POWEREASE LOANER
MEDTRONIC SOFAMOR DANEK, INC.
2300000LO
In Commercial Distribution

  • 00643169552999 ()


  • Surgical screwdriver, reusable
Mimics Enlight CMF Reconstruction Planner
Materialise NV
Reconstruction Planner
In Commercial Distribution

  • 05404028000953 ()
Reconstruction Planner

  • CAD/CAM software
Materialise Mimics Enlight CMF Orthognathic and Trauma Planner
Materialise NV
Orthognathic and Trauma Planner
In Commercial Distribution

  • 05404028000946 ()
Orthognathic and Trauma Planner

  • CAD/CAM software
Mimics Enlight CMF Reconstruction Planner
Materialise NV
Reconstruction Planner
In Commercial Distribution

  • 05404028000816 ()
Reconstruction Planner

  • CAD/CAM software
Mimics Enlight CMF Orthognathic Planner
Materialise NV
Orthognathic Planner
In Commercial Distribution

  • 05404028000809 ()
Orthognathic Planner

  • CAD/CAM software
DRIVER 4360520 T17 DRIVER
MEDTRONIC SOFAMOR DANEK, INC.
4360520
In Commercial Distribution

  • 00643169601130 ()


  • Surgical screwdriver, reusable
DRIVER 4360513 T10 DRIVER
MEDTRONIC SOFAMOR DANEK, INC.
4360513
In Commercial Distribution

  • 00643169601123 ()


  • Surgical screwdriver, reusable
DRIVER 8001201 HANDL MOD TIMESH
MEDTRONIC PS MEDICAL, INC.
8001201
In Commercial Distribution

  • 00643169497870 ()


  • General internal orthopaedic fixation system implantation kit
DRIVER 8001205 MOD SHAFT 1.6MM
MEDTRONIC PS MEDICAL, INC.
8001205
In Commercial Distribution

  • 00643169497863 ()

  • Outer Diameter: 1.6 Millimeter


  • General internal orthopaedic fixation system implantation kit
DRIVER X0914030 FLEX ARM NUT
MEDTRONIC SOFAMOR DANEK, INC.
X0914030
In Commercial Distribution

  • 00643169549241 ()


  • General internal orthopaedic fixation system implantation kit
TRAY NAV2030 NAV DRIVERS AND TAPS
MEDTRONIC SOFAMOR DANEK, INC.
NAV2030
In Commercial Distribution

  • 00643169546240 ()


  • Instrument tray, reusable
DRIVER NAV2024K SOLERA 4.75 STANDARD MAS
MEDTRONIC SOFAMOR DANEK, INC.
NAV2024K
In Commercial Distribution

  • 00643169545854 ()

  • Outer Diameter: 4.75 Millimeter


  • Surgical screwdriver, reusable
DRIVER NAV2023K SOLERA 4.75 MAS LG2
MEDTRONIC SOFAMOR DANEK, INC.
NAV2023K
In Commercial Distribution

  • 00643169545847 ()

  • Outer Diameter: 4.75 Millimeter


  • Surgical screwdriver, reusable
DRIVER NAV2022K SOLERA 5.5/6 FAS/SAS LG2
MEDTRONIC SOFAMOR DANEK, INC.
NAV2022K
In Commercial Distribution

  • 00643169545830 ()

  • Width: 5.5 Millimeter
  • Width: 6.0 Millimeter


  • Surgical screwdriver, reusable
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