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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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"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
"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
ASSY,MODULE,ISI2,CORE (89302900)
Bayer Medical Care Inc.
ISI2
In Commercial Distribution

  • 00616258027340 ()
ISI2

  • 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
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
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
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
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