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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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ASSY, Module, ISI2 (86882302)
Bayer Medical Care Inc.
ISI2
In Commercial Distribution

  • 00616258022512 ()
ISI2

  • CT contrast medium injection system, line-powered, mobile
SYSTEM,INJECTOR,MRXPERION (86410036)
BAYER MEDICAL CARE INC.
MRXperion
In Commercial Distribution

  • 00616258021355 ()
MRXP 200

  • MRI contrast medium injection system, line-powered, mobile
CT – STELLANT D DUAL INJECTOR, UPGRADED (86184524)
BAYER MEDICAL CARE INC.
Stellant D
In Commercial Distribution

  • 00616258021348 ()
SCT-210, SCT-211, SCT-212, SCT-221, SCT-222

  • CT contrast medium injection system, line-powered, mobile
DUAL,STELLANT W/CERTEGRA WKS, UPGRADED (86184516)
BAYER MEDICAL CARE INC.
Stellant D-CE
In Commercial Distribution

  • 00616258021331 ()
SCT-310, SCT-321, SCT-322

  • CT contrast medium injection system, line-powered, mobile
Cup positioner, offset
UNITED ORTHOPEDIC CORP.
9207-1303-RB
In Commercial Distribution

  • 04719886900293 ()
9207-1303-RB

  • Orthopaedic inorganic implant inserter/extractor, reusable
Cup positioner, straight
UNITED ORTHOPEDIC CORP.
9207-1103-RB
In Commercial Distribution

  • 04719886900279 ()
9207-1103-RB

  • Orthopaedic inorganic implant inserter/extractor, reusable
SCREW DRIVER 1204444 QUAD Peek Prevail
MEDTRONIC SOFAMOR DANEK, INC.
1204444
In Commercial Distribution

  • 00613994351128 ()


  • Surgical screwdriver, reusable
DRIVER 6480144 7 32 INCH BREAKOFF
MEDTRONIC SOFAMOR DANEK, INC.
6480144
In Commercial Distribution

  • 00613994331243 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
SCREWDRIVER 6480282 FIXED ANGLE
MEDTRONIC SOFAMOR DANEK, INC.
6480282
In Commercial Distribution

  • 00613994331205 ()


  • Surgical screwdriver, reusable
SCREWDRIVER 7756188 RIGHT ANGLE 2.5 HEX
MEDTRONIC SOFAMOR DANEK, INC.
7756188
In Commercial Distribution

  • 00613994330253 ()

  • 2.5mm


  • Surgical screwdriver, reusable
EXTENDER 8350110 SCREW 120MM
MEDTRONIC SOFAMOR DANEK, INC.
8350110
In Commercial Distribution

  • 00613994326027 ()

  • 3.2mm HEX


  • Surgical screwdriver, reusable
SCREWDRIVER 7967002 U JOINT
MEDTRONIC SOFAMOR DANEK, INC.
7967002
Not in Commercial Distribution

  • 00613994321220 ()


  • Surgical screwdriver, reusable
SLAP HAMMER 7967016 ACCESSORY
MEDTRONIC SOFAMOR DANEK, INC.
7967016
In Commercial Distribution

  • 00613994321091 ()


  • Surgical mallet
DRIVER GUIDE 7967030 INSTRUMENT
MEDTRONIC SOFAMOR DANEK, INC.
7967030
Not in Commercial Distribution

  • 00613994320773 ()


  • Instrument tray, reusable
DRIVER X0805149 5.5 W/O CROSSBAR 165MM
MEDTRONIC SOFAMOR DANEK, INC.
X0805149
In Commercial Distribution

  • 00613994317872 ()


  • Surgical screwdriver, reusable
TOOL 1201111 STND ALONE REV PEEK PREVAIL
MEDTRONIC SOFAMOR DANEK, INC.
1201111
In Commercial Distribution

  • 00613994309495 ()


  • Surgical screwdriver, reusable
DRIVER 8675203 5MM HEX
MEDTRONIC SOFAMOR DANEK, INC.
8675203
In Commercial Distribution

  • 00613994306265 ()


  • Surgical screwdriver, reusable
DRIVER 8675207 LONG
MEDTRONIC SOFAMOR DANEK, INC.
8675207
In Commercial Distribution

  • 00613994306227 ()


  • Surgical screwdriver, reusable
CREWDRIVER 7756187 STRAIGHT HEX
MEDTRONIC SOFAMOR DANEK, INC.
7756187
In Commercial Distribution

  • 00613994305862 ()

  • 2.5mm


  • Surgical screwdriver, reusable
DRIVER 7650091 S SCREW RETAINING
MEDTRONIC SOFAMOR DANEK, INC.
7650091
In Commercial Distribution

  • 00613994302816 ()


  • Surgical screwdriver, reusable
SCREWDRIVER 7570907 NR FANGLE
MEDTRONIC SOFAMOR DANEK, INC.
7570907
In Commercial Distribution

  • 00613994302809 ()


  • Surgical screwdriver, reusable
PLATE 9960418 3.5MM BAL END HEX SCRWDRVR
MEDTRONIC SOFAMOR DANEK, INC.
9960418
In Commercial Distribution

  • 00613994175991 ()


  • Surgical screwdriver, reusable
PLATE 9960401 TORQUE LIMITING NUT DRIVER
MEDTRONIC SOFAMOR DANEK, INC.
9960401
In Commercial Distribution

  • 00613994172037 ()


  • Orthopaedic implant driver
PLATE 9960400 THREADED NUT DRIVER
MEDTRONIC SOFAMOR DANEK, INC.
9960400
Not in Commercial Distribution

  • 00613994172020 ()


  • Surgical screwdriver, reusable
INSTRUMENT 7350145 T HNDLE BRK OFF DRIVR
MEDTRONIC SOFAMOR DANEK, INC.
7350145
In Commercial Distribution

  • 00613994166333 ()


  • Surgical screwdriver, reusable
INSTRUMENT 8114530 2.5MM HEX DRIVER
MEDTRONIC SOFAMOR DANEK, INC.
8114530
In Commercial Distribution

  • 00613994158307 ()


  • Surgical screwdriver, reusable
INSTRUMENT 8114539 COUNTERTORQUE
MEDTRONIC SOFAMOR DANEK, INC.
8114539
In Commercial Distribution

  • 00613994154682 ()


  • Surgical screwdriver, reusable
INSTR 7484147 T25 DRIVR QUIK CONECT L4.5
MEDTRONIC SOFAMOR DANEK, INC.
7484147
In Commercial Distribution

  • 00613994142825 ()

  • 3.5mm


  • Orthopaedic implant driver
INSTR 7484114 3.5MM HEX DRIVR TAPRD L4.5
MEDTRONIC SOFAMOR DANEK, INC.
7484114
In Commercial Distribution

  • 00613994142818 ()


  • Surgical screwdriver, reusable
INSTRUMENT X1205271 14MM LAP ADJUSTER
MEDTRONIC SOFAMOR DANEK, INC.
X1205271
In Commercial Distribution

  • 00613994128423 ()


  • Surgical screwdriver, reusable
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