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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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Imaging System Interface - ISI2 Module - 00616258022512

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

  • 00616258022512 ()
ISI2

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

MEDRAD® MRXperion MR Injection System - 00616258021355

SYSTEM,INJECTOR,MRXPERION (86410036)
BAYER MEDICAL CARE INC.
MRXperion
In Commercial Distribution

  • 00616258021355 ()
MRXP 200

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

MEDRAD® Stellant CT Injection System - 00616258021348

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

MEDRAD® Stellant CT Injection System - 00616258021331

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

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

MEDRAD® Stellant CT Injection System - 00616258020662

MAINTAIN,SYR HEAT,STEL,FLS2,UDI,BATCH,JA (85864483)
BAYER MEDICAL CARE INC.
SSH 200F
In Commercial Distribution

  • 00616258020662 ()
SSH 200F

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

MEDRAD® Stellant FLEX CT Injection System with Certegra® Workstation - 00616258011219

SYSTEM,DUAL,STELLANT,FLEX (85577026)
BAYER MEDICAL CARE INC.
Stellant FLEX
In Commercial Distribution

  • 00616258011219 ()
FLEX

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

MEDRAD® Stellant CT Injection System - 00616258010588

REFURBISHED SYSTEM,SNGL SYR,STELLANT SX (84856798)
BAYER MEDICAL CARE INC.
SCT121-R, SCT122-R
In Commercial Distribution

  • 00616258010588 ()
SCT121-R, SCT122-R

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