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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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MEDRAD® Stellant Imaging System Interface ISI 700 Module - 00616258008448

"Injector-Scanner Interface, ISI-700 Module (60766256)"
BAYER MEDICAL CARE INC.
ISI 700
In Commercial Distribution

  • 00616258008448 ()
ISI 700

  • CT contrast medium injection system, line-powered, mobile

MEDRAD XDS Extravasation Detection System - 00616258008189

"CT - EXTRAVASATION DETECTOR SENSOR (60727765)"
BAYER MEDICAL CARE INC.
PSA 700
In Commercial Distribution

  • 00616258008189 ()
PSA 700

  • CT contrast medium injection system, line-powered, mobile

MEDRAD XDS Extravasation Detection System - 00616258008172

"CT - EXTRAVASATION DETECTOR SYS,NON CE (60727064)"
BAYER MEDICAL CARE INC.
XDS 700
In Commercial Distribution

  • 00616258008172 ()
XDS 700

  • CT contrast medium injection system, line-powered, mobile

MEDRAD® MRXperion MR Injection System - 00616258008158

"ASSY,POLE,IV,SINGLE HOOK (84284246)"
BAYER MEDICAL CARE INC.
MRXP IV S
In Commercial Distribution

  • 00616258008158 ()
MRXP IV S

  • MRI contrast medium injection system, line-powered, mobile

MEDRAD® MRXperion MR Injection System - 00616258008141

"Assy, IV Pole, MRXperion (84290149)"
BAYER MEDICAL CARE INC.
MRXP IV D
In Commercial Distribution

  • 00616258008141 ()
MRXP IV D

  • MRI contrast medium injection system, line-powered, mobile

MEDRAD® MRXperion MR Injection System - 00616258008134

"SYSTEM,INJECTOR,MRXPERION (84200085)"
BAYER MEDICAL CARE INC.
MRXperion
In Commercial Distribution

  • 00616258008134 ()
MRXP 200

  • MRI contrast medium injection system, line-powered, mobile

Tornier Latitude - 00846832013449

TORQUE SCREWDRIVER ADAPTATOR
TORNIER, INC.
MKY122
In Commercial Distribution

  • 00846832013449 ()
MKY122

  • Surgical screwdriver, reusable

MEDRAD® Stellant CT Injection System - 00616258020860

STELLANT,SYS,INJ,D SYR,W/CERT WKS,MC,4ED (85937286)
BAYER MEDICAL CARE INC.
Stellant D-CE
In Commercial Distribution

  • 00616258020860 ()
SCT-310, SCT-321, SCT-322

  • CT contrast medium injection system, line-powered, mobile

MEDRAD® Stellant CT Injection System - 00616258020822

STELLANT,SYS,INJ,D,DUAL SYR,LATAM2,4ED (85920278)
BAYER MEDICAL CARE INC.
Stellant D-CE
In Commercial Distribution

  • 00616258020822 ()
SCT-310, SCT-321, SCT-322

  • CT contrast medium injection system, line-powered, mobile

MEDRAD® Stellant FLEX CT Injection System with Certegra® Workstation (Upgrade) - 00616258020792

SYSTEM,DUAL,STELLANT,REMANUFACTURED,FLEX (85631829)
BAYER MEDICAL CARE INC.
Stellant FLEX
In Commercial Distribution

  • 00616258020792 ()
FLEX UPG

  • CT contrast medium injection system, line-powered, mobile
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