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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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Bayer Medical Care Inc.
SCT-310, SCT-321, SCT-322
In Commercial Distribution

  • 00616258025131 ()
SCT-310, SCT-321, SCT-322

  • CT contrast medium injection system, line-powered, mobile
SYSTEM,INJECTOR,MRXPERION,CORE,LR (87838420)
Bayer Medical Care Inc.
MRXP 200
In Commercial Distribution

MRXP 200

  • MRI 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
Injector-Scanner Interface, ISI-900H Module(MODULE, HITACHI, ISI 900H)(84819484)
BAYER MEDICAL CARE INC.
ISI 900H
In Commercial Distribution

  • 00616258009766 ()
ISI 900H

  • CT contrast medium injection system, line-powered, mobile
MAINTAINER,SYR HEAT,STEL,PFS,LR (88457285)
BAYER MEDICAL CARE INC.
SSH 100F
In Commercial Distribution

  • 00616258026473 ()
SSH 100F

  • CT contrast medium injection system, line-powered, mobile
MAINTAIN,SYR HEAT,STELL,FLS2,LR (87980030)
BAYER MEDICAL CARE INC.
SSH 200F
In Commercial Distribution

  • 00616258025384 ()
SSH 200F

  • CT contrast medium injection system, line-powered, mobile
ASSY, Module, ISI2 (86882302)
Bayer Medical Care Inc.
ISI2
In Commercial Distribution

  • 00616258022512 ()
ISI2

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