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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PIN DRIVER EX0911146 EXTENDED
MEDTRONIC SOFAMOR DANEK, INC.
EX0911146
In Commercial Distribution

  • 00643169090811 ()


  • Surgical drill guide, reusable
DRIVER EX0911232 NON-BREAK OFF WHANDLE
MEDTRONIC SOFAMOR DANEK, INC.
EX0911232
In Commercial Distribution

  • 00643169089488 ()


  • Orthopaedic implant driver
DRIVER EX0811388 T27 W/MOLDED HANDLE
MEDTRONIC SOFAMOR DANEK, INC.
EX0811388
In Commercial Distribution

  • 00643169072350 ()


  • Orthopaedic implant driver
DRIVER EX0811387 T27 QUICK CONNECT
MEDTRONIC SOFAMOR DANEK, INC.
EX0811387
In Commercial Distribution

  • 00643169072343 ()


  • Orthopaedic implant driver
CONTAINER 9734863 SOLERA TAPS DRIVERS
MEDTRONIC NAVIGATION, INC.
9734863
In Commercial Distribution

  • 00643169070035 ()


  • Device sterilization/disinfection container, reusable
Tapered Driver Size 10
K2M, INC.
K2-02-2180-01
In Commercial Distribution

  • 10888857309883 ()
K2-02-2180-01

  • Orthopaedic prosthesis implantation positioning instrument, reusable
DRIVER EX0212730 TAPERED SQUARE
MEDTRONIC SOFAMOR DANEK, INC.
EX0212730
In Commercial Distribution

  • 00643169149977 ()


  • Orthopaedic implant driver
Semi-Adj Transverse Connector Single Slot, Size 28 mm
K2M, INC.
5401-70028A
In Commercial Distribution

  • 10888857291270 ()

  • Length: 28 Millimeter
  • Outer Diameter: 6 Millimeter
  • Outer Diameter: 5.5 Millimeter
5401-70028A

  • Cannulated surgical drill bit, single-use
Semi-Adj Transverse Connector Dual Slot, Size 34 mm
K2M, INC.
5401-70034A
In Commercial Distribution

  • 10888857291263 ()

  • Outer Diameter: 6 Millimeter
  • Length: 34 Millimeter
  • Outer Diameter: 5.5 Millimeter
5401-70034A

  • Cannulated surgical drill bit, single-use
Semi-Adj Transverse Connector Dual Slot, Size 40 mm
K2M, INC.
5401-70040A
In Commercial Distribution

  • 10888857291256 ()

  • Outer Diameter: 6 Millimeter
  • Length: 40 Millimeter
  • Outer Diameter: 5.5 Millimeter
5401-70040A

  • Cannulated surgical drill bit, single-use
Semi-Adj Transverse Connector Single Slot, Size 31 mm
K2M, INC.
5401-70031A
In Commercial Distribution

  • 10888857291249 ()

  • Length: 31 Millimeter
  • Outer Diameter: 5.5 Millimeter
  • Outer Diameter: 6 Millimeter
5401-70031A

  • Cannulated surgical drill bit, single-use
Semi-Adj Transverse Connector Dual Slot, Size 37 mm
K2M, INC.
5401-70037A
In Commercial Distribution

  • 10888857291232 ()

  • Length: 37 Millimeter
  • Outer Diameter: 6 Millimeter
  • Outer Diameter: 5.5 Millimeter
5401-70037A

  • Cannulated surgical drill bit, single-use
Semi-Adj Transverse Connector Dual Slot, Size 43 mm
K2M, INC.
5401-70043A
In Commercial Distribution

  • 10888857291225 ()

  • Length: 43 Millimeter
  • Outer Diameter: 5.5 Millimeter
  • Outer Diameter: 6 Millimeter
5401-70043A

  • Cannulated surgical drill bit, single-use
Transverse Connector, Adjustable, Size 45 mm - 48 mm
K2M, INC.
5401-74548
In Commercial Distribution

  • 10888857291195 ()

  • Length: 45 Millimeter
  • Outer Diameter: 6 Millimeter
  • Outer Diameter: 5.5 Millimeter
5401-74548

  • Cannulated surgical drill bit, single-use
Transverse Connector, Adjustable, Size 50 mm - 58 mm
K2M, INC.
5401-75058
In Commercial Distribution

  • 10888857291188 ()

  • Outer Diameter: 6 Millimeter
  • Length: 50 Millimeter
  • Outer Diameter: 5.5 Millimeter
5401-75058

  • Cannulated surgical drill bit, single-use
Transverse Connector, Adjustable, Size 47 mm - 52 mm
K2M, INC.
5401-74752
In Commercial Distribution

  • 10888857291171 ()

  • Length: 47 Millimeter
  • Outer Diameter: 5.5 Millimeter
  • Outer Diameter: 6 Millimeter
5401-74752

  • Cannulated surgical drill bit, single-use
Provisional Split Driver Size 30 Small Handle
K2M, INC.
5101-90193
In Commercial Distribution

  • 10888857290662 ()
5101-90193

  • Orthopaedic implant driver
Driver Sleeve
K2M, INC.
5101-90186
In Commercial Distribution

  • 10888857283428 ()
5101-90186

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Rod Pusher XT
K2M, INC.
5101-90177
In Commercial Distribution

  • 10888857279421 ()
5101-90177

  • Orthopaedic implant driver
Lordosis/Kyphosis Driver Inner Shaft, Size Inner Shaft
K2M, INC.
2112-90053
In Commercial Distribution

  • 10888857279209 ()
2112-90053

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Lordosis/Kyphosis Driver Outer Shaft, Size Outer Shaft
K2M, INC.
2112-90052
In Commercial Distribution

  • 10888857279148 ()
2112-90052

  • Orthopaedic prosthesis implantation positioning instrument, reusable
HANDLED DRIVER EX0212035 NUT
MEDTRONIC SOFAMOR DANEK, INC.
EX0212035
In Commercial Distribution

  • 00643169142169 ()


  • Orthopaedic implant driver
Distractor Driver
K2M, INC.
7902-90092
In Commercial Distribution

  • 10888857399112 ()
7902-90092

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Tapered Driver Size 27, Long
K2M, INC.
7012-90103
In Commercial Distribution

  • 10888857398382 ()
7012-90103

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Expansion Driver, Size Long
K2M, INC.
7012-90094
In Commercial Distribution

  • 10888857394025 ()
7012-90094

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Driver, Size 8
K2M, INC.
7012-90095
In Commercial Distribution

  • 10888857391697 ()
7012-90095

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Provisional Screwdriver (Long) Size 30
K2M, INC.
2901-90215
In Commercial Distribution

  • 10888857389175 ()
2901-90215

  • Orthopaedic implant driver
Provisional Screwdriver (Short) Size 30
K2M, INC.
2901-90214
In Commercial Distribution

  • 10888857389168 ()
2901-90214

  • Orthopaedic implant driver
Driver Cricket 2
K2M, INC.
6201-90095
In Commercial Distribution

  • 10888857386570 ()
6201-90095

  • Orthopaedic implant driver
FAST Tapered Driver Size 10
K2M, INC.
8801-90033
In Commercial Distribution

  • 10888857384200 ()
8801-90033

  • Orthopaedic implant driver
Plate Assembly Driver Tapered
K2M, INC.
7902-90034
In Commercial Distribution

  • 10888857383715 ()
7902-90034

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Universal Driver Size 20
K2M, INC.
SP-2460
In Commercial Distribution

  • 10888857383494 ()

  • Size 20 Hexalobe
SP-2460

  • Orthopaedic prosthesis implantation positioning instrument, reusable
90° Driver Size 20
K2M, INC.
7601-90132
In Commercial Distribution

  • 10888857383104 ()
7601-90132

  • Orthopaedic prosthesis implantation positioning instrument, reusable
90° Driver Size 20 Tapered
K2M, INC.
7601-90130
In Commercial Distribution

  • 10888857383098 ()
7601-90130

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Hard metal tip, straight (for Eby band seater REF 051-023-00)
DENTAURUM GmbH & Co.KG
051-025-00
Not in Commercial Distribution

  • J011051025000 ()


  • Orthodontic metal band pusher
Hard metal tip, curved (for Eby band seater REF 051-023-00)
DENTAURUM GmbH & Co.KG
051-024-00
Not in Commercial Distribution

  • J011051024000 ()


  • Orthodontic metal band pusher
Eby band seater, curved, Stainless steel
DENTAURUM GmbH & Co.KG
051-023-00
Not in Commercial Distribution

  • J011051023000 ()


  • Orthodontic metal band pusher
Exchange Tip,Straight
DENTAURUM GmbH & Co.KG
051-022-00
Not in Commercial Distribution

  • J011051022000 ()


  • Orthodontic metal band pusher
NGO motor driver 1503185-001 Update of the motor control board of the console OPTIMA MX: Added a switch motor on top of the motor board that can control up to 3 motors.
Bien-Air Dental SA
1503185-001
In Commercial Distribution

  • J00715031850011 ()


  • Dental surgical power tool motor, electric
iChiropro console a driver designed to drive Bien-Air Dental SA's dental micromotors, via an Apple iDevice (iPod or iPad).
Bien-Air Dental SA
1400052
In Commercial Distribution

  • J00714000520521 ()
1400052

  • Surgical power tool system control unit, line-powered
  • Dental treatment application software
iChiropro console a driver designed to drive Bien-Air Dental SA's dental micromotors, via an Apple iDevice (iPod or iPad).
Bien-Air Dental SA
1400051
In Commercial Distribution

  • J00714000510511 ()
1400051

  • Surgical power tool system control unit, line-powered
EXTENDER 7578302 5.5/6.0 EXTENDER BODY
MEDTRONIC SOFAMOR DANEK, INC.
7578302
In Commercial Distribution

  • 00643169177055 ()


  • Surgical screwdriver, reusable
DRIVER 5584928 FAS
MEDTRONIC SOFAMOR DANEK, INC.
5584928
In Commercial Distribution

  • 00643169177031 ()


  • Surgical screwdriver, reusable
DRIVER 5584339 5.5/6.0 EAC FAS
MEDTRONIC SOFAMOR DANEK, INC.
5584339
In Commercial Distribution

  • 00643169175648 ()


  • Orthopaedic implant driver
DRIVER EX0312670 BALL HANDLE
MEDTRONIC SOFAMOR DANEK, INC.
EX0312670
In Commercial Distribution

  • 00643169174177 ()


  • Orthopaedic implant driver
SCREWDRIVER EX1011036 T20
MEDTRONIC SOFAMOR DANEK, INC.
EX1011036
In Commercial Distribution

  • 00643169174160 ()


  • Surgical screwdriver, reusable
DRIVER EX0412058 SHORT T25
MEDTRONIC SOFAMOR DANEK, INC.
EX0412058
In Commercial Distribution

  • 00643169173293 ()


  • Surgical drill guide, reusable
DRIVER EX0212740 3.2MM BALL TIP
MEDTRONIC SOFAMOR DANEK, INC.
EX0212740
In Commercial Distribution

  • 00643169167117 ()


  • Orthopaedic implant driver
DRIVER EX0312093 T-27 EXTENDED SHAFT
MEDTRONIC SOFAMOR DANEK, INC.
EX0312093
In Commercial Distribution

  • 00643169165601 ()


  • Surgical drill guide, reusable
DRIVER 5484901 4.75 RETAINING MAS DRIVER
MEDTRONIC SOFAMOR DANEK, INC.
5484901
In Commercial Distribution

  • 00643169163089 ()


  • Surgical screwdriver, reusable
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