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 NAV2025 SOLERA 4.75 REDUCT MAS
MEDTRONIC SOFAMOR DANEK, INC.
NAV2025
In Commercial Distribution

  • 00643169347441 ()


  • Surgical screwdriver, reusable
DRIVER EX0313282 SETSCREW
MEDTRONIC SOFAMOR DANEK, INC.
EX0313282
In Commercial Distribution

  • 00643169345027 ()


  • Orthopaedic implant driver
SCREWDRIVER EX0413002 STRAIGHT 2.1MM SQ.
MEDTRONIC SOFAMOR DANEK, INC.
EX0413002
In Commercial Distribution

  • 00643169345010 ()


  • Orthopaedic implant driver
DRIVER X0513072 GECKO
MEDTRONIC SOFAMOR DANEK, INC.
X0513072
In Commercial Distribution

  • 00643169383135 ()


  • Orthopaedic implant driver
DRIVER X0613077 2.5MM HEX CANNULATED
MEDTRONIC SOFAMOR DANEK, INC.
X0613077
In Commercial Distribution

  • 00643169376502 ()


  • Orthopaedic implant driver
DRIVER 5107463 OLIF51 PIN DRIVER
MEDTRONIC SOFAMOR DANEK, INC.
5107463
In Commercial Distribution

  • 00643169373372 ()


  • General internal orthopaedic fixation system implantation kit
DRIVER EX06131021 T27
MEDTRONIC SOFAMOR DANEK, INC.
EX06131021
In Commercial Distribution

  • 00643169371705 ()


  • Orthopaedic implant driver
TOOL 3036024 2.0MM SCREW REMOVAL TOOL
MEDTRONIC SOFAMOR DANEK, INC.
3036024
In Commercial Distribution

  • 00643169363533 ()

  • 2mm


  • Surgical screwdriver, reusable
DRIVER 6630904 T8/T10 DRIVER
MEDTRONIC SOFAMOR DANEK, INC.
6630904
In Commercial Distribution

  • 00643169363496 ()


  • Surgical screwdriver, reusable
DRIVER 6630905 NO-P ANGLED DRIVER
MEDTRONIC SOFAMOR DANEK, INC.
6630905
In Commercial Distribution

  • 00643169363489 ()


  • Orthopaedic implant driver
DRIVER 9010000510 T27
MEDTRONIC SOFAMOR DANEK, INC.
9010000510
In Commercial Distribution

  • 00643169408524 ()


  • Orthopaedic implant driver
MAS DRIVER EX0913068 RETAIN. BONESCR.T25
MEDTRONIC SOFAMOR DANEK, INC.
EX0913068
In Commercial Distribution

  • 00643169408289 ()


  • Orthopaedic implant driver
DRIVER EX0713173 T-25 TAPERED
MEDTRONIC SOFAMOR DANEK, INC.
EX0713173
In Commercial Distribution

  • 00643169398788 ()


  • Orthopaedic implant driver
Driver, Size 10
K2M, INC.
7902-90104
In Commercial Distribution

  • 10888857443037 ()

  • Size 10
7902-90104

  • Orthopaedic prosthesis implantation positioning instrument, reusable
SCREWDRIVER X0714014 FIXED AXIAL
MEDTRONIC SOFAMOR DANEK, INC.
X0714014
In Commercial Distribution

  • 00643169785939 ()


  • Orthopaedic implant driver
SCREWDRIVER X0714013 MULTI AXIAL
MEDTRONIC SOFAMOR DANEK, INC.
X0714013
In Commercial Distribution

  • 00643169785922 ()


  • Orthopaedic implant driver
DRIVER 6550031 5.5/6.0 SV NUT DRIVER
MEDTRONIC SOFAMOR DANEK, INC.
6550031
In Commercial Distribution

  • 00643169785687 ()


  • Surgical screwdriver, reusable
SCREWDRIVER EX0416052 U JOINT T25
MEDTRONIC SOFAMOR DANEK, INC.
EX0416052
In Commercial Distribution

  • 00643169783652 ()


  • 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
Flexible Screwdriver Shaft (3.5mm Hex)
X-BOLT ORTHOPEDICS INC.
XNI-023
In Commercial Distribution

  • 05397283000212 ()


  • Surgical screwdriver, reusable
Short Screwdriver Shaft (3.5mm Hex)
X-BOLT ORTHOPEDICS INC.
XNI-022
In Commercial Distribution

  • 05397283000205 ()


  • Surgical screwdriver, reusable
Long Screwdriver Shaft (3.5mm Hex)
X-BOLT ORTHOPEDICS INC.
XNI-021
In Commercial Distribution

  • 05397283000199 ()


  • Surgical screwdriver, reusable
T20 Torx screwdriver (4.5Nm Torque Limit)
X-BOLT ORTHOPEDICS INC.
XNI-020
In Commercial Distribution

  • 05397283000182 ()


  • Surgical screwdriver, reusable
Drive 5.0
Artelon
TA500
In Commercial Distribution

  • 00850003396347 ()
TA500

  • Tendon/ligament bone anchor, non-bioabsorbable
  • Surgical screwdriver, single-use
Drive 3.85
Artelon
TA385
In Commercial Distribution

  • 00850003396330 ()
TA385

  • Tendon/ligament bone anchor, non-bioabsorbable
  • Surgical screwdriver, single-use
TWIST.30
Artelon
TW030
In Commercial Distribution

  • 00850003396323 ()
TW030

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
  • Tendon/ligament bone anchor, non-bioabsorbable
  • Surgical screwdriver, single-use
Solid Pilot Tip Drill Bit Kit
Artelon
61012
In Commercial Distribution

  • 00850003396316 ()

  • Outer Diameter: 4.5 Millimeter
61012

  • Cannulated surgical drill bit, single-use
Cannulated Drill Bit
Artelon
61015
In Commercial Distribution

  • 00850003396279 ()

  • Outer Diameter: 4.5 Millimeter
61015

  • Cannulated surgical drill bit, single-use
TWIST.12
Artelon
TW012
In Commercial Distribution

  • 00850003396248 ()
TW012

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
  • Tendon/ligament bone anchor, non-bioabsorbable
  • Surgical screwdriver, single-use
Solid Pilot Tip Drill Bit Kit
Artelon
61018
In Commercial Distribution

  • 00850003396200 ()

  • Outer Diameter: 4.5 Millimeter
61018

  • Cannulated surgical drill bit, single-use
Socket Driver
K2M, INC.
5401-90005
In Commercial Distribution

  • 10888857152939 ()
5401-90005

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Socket Driver Shaft
K2M, INC.
5401-90014
In Commercial Distribution

  • 10888857227101 ()
5401-90014

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Universal Joint Driver, Hex Size 25
K2M, INC.
801-90093
In Commercial Distribution

  • 10888857143388 ()
801-90093

  • Orthopaedic prosthesis implantation positioning instrument, reusable
DRIVER EX0317005 T8
MEDTRONIC SOFAMOR DANEK, INC.
EX0317005
In Commercial Distribution

  • 00643169980662 ()


  • Surgical screwdriver, reusable
DRIVER EX0317004 T10
MEDTRONIC SOFAMOR DANEK, INC.
EX0317004
In Commercial Distribution

  • 00643169980655 ()


  • Surgical screwdriver, reusable
ATHERECTOMY H1-14550 CUTTER DRIVER UNI
Covidien LP
H1-14550
In Commercial Distribution

  • 00643169968554 ()


  • Mechanical atherectomy system catheter, peripheral
DRIVER X0715098 TWISTED T-25 W/ HANDLE
MEDTRONIC SOFAMOR DANEK, INC.
X0715098
In Commercial Distribution

  • 00643169966604 ()


  • Surgical screwdriver, reusable
SLEEVE EX1216071 2.5 HEX SCREW DRIVER
MEDTRONIC SOFAMOR DANEK, INC.
EX1216071
In Commercial Distribution

  • 00643169966598 ()


  • Surgical implant/trial-implant/sizer holder, reusable
SLEEVE EX0217044 2.5 HEX SCREW DRIVER
MEDTRONIC SOFAMOR DANEK, INC.
EX0217044
In Commercial Distribution

  • 00643169966581 ()


  • Surgical implant/trial-implant/sizer holder, reusable
Headless Compression System 2.0mm Hex Driver Shaft Cannulated
Osteocentric Technologies, Inc.
EX01-0033
In Commercial Distribution

  • 00850015496394 ()
EX01-0033

  • Surgical screwdriver, reusable
Headless Compression System 1.5mm Hex Driver Shaft Cannulated
Osteocentric Technologies, Inc.
EX01-0032
In Commercial Distribution

  • 00850015496387 ()
EX01-0032

  • Surgical screwdriver, reusable
Lumbar Interbody Fusion System (OLLIF) Mallet
ADVANCED RESEARCH MEDICAL LLC
01-11
In Commercial Distribution

  • 00850014575489 ()
01-11

  • Surgical mallet
SCREWDRIVER EX0915017 SHAFT
MEDTRONIC SOFAMOR DANEK, INC.
EX0915017
In Commercial Distribution

  • 00643169694125 ()


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

  • 00643169693838 ()

  • Outer Diameter: 4.75 Millimeter


  • Surgical screwdriver, reusable
DRIVER NAV2024 SOLERA 4.75 STANDARD MAS
MEDTRONIC SOFAMOR DANEK, INC.
NAV2024
In Commercial Distribution

  • 00643169693821 ()


  • Surgical screwdriver, reusable
PENFIELD X1015037 6.5 PUSH/PULL
MEDTRONIC SOFAMOR DANEK, INC.
X1015037
In Commercial Distribution

  • 00643169693715 ()


  • Surgical screwdriver, reusable
ADAPTER X1015013 INLINE
MEDTRONIC SOFAMOR DANEK, INC.
X1015013
In Commercial Distribution

  • 00643169693678 ()


  • Orthopaedic implant driver
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