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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
#8 STAR SCREW DRIVER BIT
TORNIER, INC.
7000002
In Commercial Distribution

  • 00846832004683 ()
7000002

  • Surgical screwdriver, reusable
HEX SCREW DRIVER BIT
TORNIER, INC.
7000001
In Commercial Distribution

  • 00846832004676 ()

  • Outer Diameter: 2.5 Millimeter
7000001

  • Surgical screwdriver, reusable
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
AO RATCHETING DRIVER HANDLE
TORNIER, INC.
AFPDRAO
Not in Commercial Distribution

  • 00846832000951 ()
AFPDRAO

  • Surgical instrument handle, non-torque-limiting
CLARITY II, T-HANDLE DRIVER
Pioneer Surgical Technology, Inc.
725-130
Not in Commercial Distribution

  • 00846468099510 ()
725-130

  • Surgical retraction system, reusable
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