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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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SMART GBS AND SMARTCYCLE DX SYSTEM AND SOFTWARE, VERSION 1.7B
CEPHEID
SC2500N13-1
In Commercial Distribution

  • 07332940004569 ()
SC2500N13-1

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
SMART GBS AND SMARTCYCLE DX SYSTEM AND SOFTWARE, VERSION 1.7B
CEPHEID
SC2500N14-1
In Commercial Distribution

  • 07332940004545 ()
SC2500N14-1

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
SMART GBS AND SMARTCYCLE DX SYSTEM AND SOFTWARE, VERSION 1.7B
CEPHEID
SC2500N15-1
In Commercial Distribution

  • 07332940004538 ()
SC2500N15-1

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
SMART GBS AND SMARTCYCLE DX SYSTEM AND SOFTWARE, VERSION 1.7B
CEPHEID
SC2500N16-1
In Commercial Distribution

  • 07332940004521 ()
SC2500N16-1

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
Panther Fusion® Internal Control-X.
Hologic, Inc.
INTERNAL CONTROL-X, 960T, IVD
In Commercial Distribution

  • 15420045510470 ()
PRD-04476

  • Exogenous DNA/RNA internal control IVD, kit
No Description
Biomet Orthopedics, LLC
31-311312
In Commercial Distribution

  • 00880304675698 ()

  • SIZE B 60MM HIGH OFFSET
31-311312

  • Femoral stem prosthesis trial
No Description
Biomet Orthopedics, LLC
31-311302
In Commercial Distribution

  • 00880304675629 ()

  • SIZE B 60MM STANDARD OFFSET
31-311302

  • Femoral stem prosthesis trial
No Description
Biomet Orthopedics, LLC
31-301312
In Commercial Distribution

  • 00880304489998 ()

  • SIZE B 60MM HIGH OFFSET
31-301312

  • Femoral stem prosthesis trial
No Description
Biomet Orthopedics, LLC
31-301342
In Commercial Distribution

  • 00880304489967 ()

  • SIZE B 80MM STANDARD OFFSET
31-301342

  • Femoral stem prosthesis trial
No Description
Biomet Orthopedics, LLC
31-301352
In Commercial Distribution

  • 00880304489806 ()

  • SIZE B 80MM HIGH OFFSET
31-301352

  • Femoral stem prosthesis trial
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