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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 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
Screw, 5mm, Burr Hole Cover
ST. JUDE MEDICAL, INC.
6015
In Commercial Distribution

  • 15414734403075 ()
  • 05414734403078 ()
6015

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
Cranial Burr Hole Cover Sys.
ST. JUDE MEDICAL, INC.
6010
In Commercial Distribution

  • 05414734403061 ()
6010

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
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 EX0416035 5.5/6.0 FAS
MEDTRONIC SOFAMOR DANEK, INC.
EX0416035
In Commercial Distribution

  • 00643169764194 ()


  • Surgical screwdriver, reusable
DRIVER EX0514021 TAPERED HEX 3.2MM
MEDTRONIC SOFAMOR DANEK, INC.
EX0514021
In Commercial Distribution

  • 00643169523562 ()


  • Orthopaedic implant driver
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
Laparoscopy wound closure system pack consists of: 05391529640439; neoClose Anchor (Long Driver) x 2 US; Model Number NCAALX2-U
NEOSURGICAL LIMITED
NCAALX2-U
In Commercial Distribution

  • 05391529640569 ()
  • 05391529640552 ()
  • 05391529640439 ()


  • Laparoscopic wound closure thread
Flexible IM Reamer Shaft 650mm
ORTHOXEL DESIGNATED ACTIVITY COMPANY
INS-1156
In Commercial Distribution

  • 05391529588700 ()

  • 3.2 x 227.0mm
INS-1156

  • Medullary canal orthopaedic reamer shaft
Flexible Hex Driver Ball Tip (5mm/8mm)
ORTHOXEL DESIGNATED ACTIVITY COMPANY
INS-1151
In Commercial Distribution

  • 05391529588656 ()

  • Ø7.92 x 195mm
INS-1151

  • Surgical screwdriver, reusable
Flexible IM reamer Shaft 470mm
ORTHOXEL DESIGNATED ACTIVITY COMPANY
INS-1095
In Commercial Distribution

  • 05391529583057 ()

  • 470.0 mm
INS-1095

  • Medullary canal orthopaedic reamer shaft
Long Screw Hex Driver (3.5mm)
ORTHOXEL DESIGNATED ACTIVITY COMPANY
INS-1078
In Commercial Distribution

  • 05391529582883 ()
INS-1078

  • Surgical screwdriver, reusable
Short Screw Hex Driver (3.5mm)
ORTHOXEL DESIGNATED ACTIVITY COMPANY
INS-1077
In Commercial Distribution

  • 05391529582876 ()
INS-1077

  • Surgical screwdriver, reusable
Short Screw Driver With Retention Hex (3.5mm)
ORTHOXEL DESIGNATED ACTIVITY COMPANY
INS-1076
In Commercial Distribution

  • 05391529582869 ()
INS-1076

  • Surgical screwdriver, reusable
Hex Driver (5mm/8mm)
ORTHOXEL DESIGNATED ACTIVITY COMPANY
INS-1075
In Commercial Distribution

  • 05391529582852 ()
INS-1075

  • Surgical screwdriver, reusable
Mallet
ORTHOXEL DESIGNATED ACTIVITY COMPANY
INS-1065
In Commercial Distribution

  • 05391529582760 ()
INS-1065

  • Surgical mallet
Long Screw Driver With Retention Hex (3.5mm)
ORTHOXEL DESIGNATED ACTIVITY COMPANY
INS-1060
In Commercial Distribution

  • 05391529582739 ()
INS-1060

  • Surgical screwdriver, reusable
Driver With Retention Hex (5mm)
ORTHOXEL DESIGNATED ACTIVITY COMPANY
INS-1059
In Commercial Distribution

  • 05391529582722 ()
INS-1059

  • Surgical screwdriver, reusable
Long Removal and Insertion Hex (5mm)
ORTHOXEL DESIGNATED ACTIVITY COMPANY
INS-1136
In Commercial Distribution

  • 05391529581855 ()
INS-1136

  • Surgical screwdriver, reusable
Flexible IM Reamer Shaft Extension 150mm
ORTHOXEL DESIGNATED ACTIVITY COMPANY
INS-1135
In Commercial Distribution

  • 05391529581640 ()

  • 150 mm
INS-1135

  • Medullary canal orthopaedic reamer shaft
DRIVER X0814002 T25 QC THK SHAFT
MEDTRONIC SOFAMOR DANEK, INC.
X0814002
In Commercial Distribution

  • 00643169541375 ()


  • Orthopaedic implant driver
PIN X0514003 PLATE HOLDING
MEDTRONIC SOFAMOR DANEK, INC.
X0514003
In Commercial Distribution

  • 00643169541351 ()


  • External spinal fixation system
DRIVER 9735253K T-HANDLE 5MM HEX KIT
MEDTRONIC NAVIGATION, INC.
9735253K
In Commercial Distribution

  • 00643169540552 ()

  • 5mm


  • Multi-purpose stereotactic surgery system
DRIVER EX0614091 T-25 330 LG SLR HANDLE
MEDTRONIC SOFAMOR DANEK, INC.
EX0614091
Not in Commercial Distribution

  • 00643169513792 ()


  • Orthopaedic implant driver
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