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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Alert Display Driver (ADD) - Configuration 1
AMPLION CLINICAL COMMUNICATIONS, INC.
D-ADD-X-1
Not in Commercial Distribution

  • 00850016398017 ()
D-ADD-X-1

  • Nurse call system
Midface Reconstruction kit
Materialise NV
SD980.032
In Commercial Distribution

  • 05420060380761 ()
SD980.032

  • Custom-made organ/bone anatomy model/surgical guide kit
Mandible Reconstruction kit
Materialise NV
SD980.031
In Commercial Distribution

  • 05420060380754 ()
SD980.031

  • Custom-made organ/bone anatomy model/surgical guide kit
Titanium 3D Printed Guide, Bone harvesting
Materialise NV
SD980.028
In Commercial Distribution

  • 05420060380747 ()
SD980.028

  • Custom-made orthopaedic/craniofacial surgical guide
Inserter, Medial Bunion-Alt Distal (Right)
Sky Surgical, LLC
001-2-11-R
In Commercial Distribution

  • 00850024702493 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable
Inserter, Medial Bunion-Alt Distal (Left)
Sky Surgical, LLC
001-2-11-L
In Commercial Distribution

  • 00850024702486 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable
Inserter, Dorsal Bunion (Right)
Sky Surgical, LLC
001-2-10-R
In Commercial Distribution

  • 00850024702479 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable
Inserter, Dorsal Bunion (Left)
Sky Surgical, LLC
001-2-10-L
In Commercial Distribution

  • 00850024702462 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable
Screwdriver Bit, T6 Tapered
Sky Surgical, LLC
001-1-07
In Commercial Distribution

  • 00850024702448 ()


  • Surgical screwdriver, reusable
Inserter, Medial Bunion (Right)
Sky Surgical, LLC
001-2-04-R
In Commercial Distribution

  • 00850024702363 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable
Inserter, Hallux Limitus/Dorsal Bunion
Sky Surgical, LLC
001-2-09
In Commercial Distribution

  • 00850024702356 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable
Inserter, Medial Bunion (Left)
Sky Surgical, LLC
001-2-04-L
In Commercial Distribution

  • 00850024702349 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable
SCREWDRIVER X1215024 LNG MAS LOCK SLEEVE
MEDTRONIC SOFAMOR DANEK, INC.
X1215024
In Commercial Distribution

  • 00643169713949 ()


  • Surgical screwdriver, reusable
DRIVER EX1115089 TAPERED T27 243MM
MEDTRONIC SOFAMOR DANEK, INC.
EX1115089
In Commercial Distribution

  • 00643169713666 ()


  • Orthopaedic implant driver
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
DRIVER X1015012 INLINE
MEDTRONIC SOFAMOR DANEK, INC.
X1015012
In Commercial Distribution

  • 00643169693661 ()


  • Orthopaedic implant driver
DRIVER 7480755T 5.5/6.0 MAS LOCK SLEEVE
MEDTRONIC SOFAMOR DANEK, INC.
7480755T
In Commercial Distribution

  • 00643169679429 ()


  • Orthopaedic implant driver
SHAFT 7480741T ADAPTER DRIVER QC SHAFT
MEDTRONIC SOFAMOR DANEK, INC.
7480741T
In Commercial Distribution

  • 00643169679405 ()


  • Orthopaedic implant driver
ADAPTER X0815099 OFFSET
MEDTRONIC SOFAMOR DANEK, INC.
X0815099
In Commercial Distribution

  • 00643169674592 ()


  • Orthopaedic implant driver
DRIVER X0815096 OFFSET
MEDTRONIC SOFAMOR DANEK, INC.
X0815096
In Commercial Distribution

  • 00643169674561 ()


  • Orthopaedic implant driver
DRIVER X0715045 NUT 20MM 3-LUG
MEDTRONIC SOFAMOR DANEK, INC.
X0715045
In Commercial Distribution

  • 00643169662667 ()


  • Orthopaedic implant driver
DRIVER EX0116014 T25 RETAINING TWIST
MEDTRONIC SOFAMOR DANEK, INC.
EX0116014
In Commercial Distribution

  • 00643169723351 ()


  • Surgical screwdriver, reusable
SLEEVE EX1015066 SCREW DRIVER
MEDTRONIC SOFAMOR DANEK, INC.
EX1015066
In Commercial Distribution

  • 00643169722200 ()


  • Orthopaedic implantation sleeve, reusable
STARTER 5580135 SETSCREW T27
MEDTRONIC SOFAMOR DANEK, INC.
5580135
In Commercial Distribution

  • 00643169714731 ()


  • Surgical screwdriver, reusable
DRIVER EX0416035 5.5/6.0 FAS
MEDTRONIC SOFAMOR DANEK, INC.
EX0416035
In Commercial Distribution

  • 00643169764194 ()


  • Surgical screwdriver, reusable
DRIVER 6550006 5.5/6.0 SV SET SCREW DRVR
MEDTRONIC SOFAMOR DANEK, INC.
6550006
In Commercial Distribution

  • 00643169754539 ()


  • Surgical screwdriver, reusable
DRIVER NAV6550005 5.5/6.0 SV NAV MAS
MEDTRONIC SOFAMOR DANEK, INC.
NAV6550005
In Commercial Distribution

  • 00643169754522 ()


  • Surgical screwdriver, reusable
DRIVER 6550004 BALL-ENDED DRIVER
MEDTRONIC SOFAMOR DANEK, INC.
6550004
In Commercial Distribution

  • 00643169754515 ()


  • Surgical screwdriver, reusable
DRIVER 6550003 5.5/6.0 SV NON-RETAINING
MEDTRONIC SOFAMOR DANEK, INC.
6550003
In Commercial Distribution

  • 00643169754508 ()


  • Surgical screwdriver, reusable
DRIVER 6550002 5.5/6.0 SV MAS DRIVER
MEDTRONIC SOFAMOR DANEK, INC.
6550002
In Commercial Distribution

  • 00643169754492 ()


  • Surgical screwdriver, reusable
DRIVER EX0316044 T-HANDLE
MEDTRONIC SOFAMOR DANEK, INC.
EX0316044
In Commercial Distribution

  • 00643169747678 ()


  • Orthopaedic implant driver
DRIVER EX0216058 NUT
MEDTRONIC SOFAMOR DANEK, INC.
EX0216058
In Commercial Distribution

  • 00643169746831 ()


  • Surgical instrument handle, non-torque-limiting
DRIVER EX0216057 THREADED ROD
MEDTRONIC SOFAMOR DANEK, INC.
EX0216057
In Commercial Distribution

  • 00643169746824 ()


  • Surgical instrument handle, non-torque-limiting
DRIVER X0116073 PLATE HOLDING PIN
MEDTRONIC SOFAMOR DANEK, INC.
X0116073
In Commercial Distribution

  • 00643169731530 ()


  • General internal orthopaedic fixation system implantation kit
DRIVER EX0116074 NUT
MEDTRONIC SOFAMOR DANEK, INC.
EX0116074
In Commercial Distribution

  • 00643169731462 ()


  • General internal orthopaedic fixation system implantation kit
SCREWDRIVER NAV3606195 NAVIGATD THREADED
MEDTRONIC SOFAMOR DANEK, INC.
NAV3606195
In Commercial Distribution

  • 00643169725461 ()


  • 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
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
Mimics Enlight CMF Orthognathic Planner
Materialise NV
Orthognathic Planner
In Commercial Distribution

  • 05404028000809 ()
Orthognathic Planner

  • CAD/CAM software
DRIVER 7480745T 4.75 MAS LOCK SLEEVE
MEDTRONIC SOFAMOR DANEK, INC.
7480745T
In Commercial Distribution

  • 00643169679412 ()


  • Orthopaedic implant driver
DRIVER NAV2081K VERT THREADED
MEDTRONIC SOFAMOR DANEK, INC.
NAV2081K
In Commercial Distribution

  • 00643169672857 ()


  • Surgical screwdriver, reusable
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