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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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SALINE INFUSION PUMP (SIP)
Cardiovascular Systems, Inc.
SIP-3000
In Commercial Distribution

  • 10852528005442 ()
7-10037-01

  • Atherectomy system saline/lubricant pump
DIAMONDBACK CORONARY, CLASSIC CROWN, 1.25MM, 135CM SHAFT
Cardiovascular Systems, Inc.
DBEC-125
In Commercial Distribution

  • 10850026568698 ()

  • Low Speed 80krpm
  • Medium Speed krpm
  • High Speed 120krpm
  • Crown Type Classic
  • Max OD 0.0495in
  • Intro Sheath 6Fr
  • Crown Diameter 1.25mm
  • Nose Length 5mm
  • Shaft Length: 135 Centimeter
  • Guidewire Size OD 0.012in
7-10098-01

  • Mechanical atherectomy system, coronary, line-powered
SMART GBS AND SMARTCYCLE DX SYSTEM AND SOFTWARE, VERSION 1.7B
CEPHEID
SC2500N17-1
In Commercial Distribution

  • 07332940004910 ()
SC2500N17-1

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
SMART GBS AND SMARTCYCLE DX SYSTEM AND SOFTWARE, VERSION 1.7B
CEPHEID
SC2500N18-1
In Commercial Distribution

  • 07332940004903 ()
SC2500N18-1

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
SMART GBS AND SMARTCYCLE DX SYSTEM AND SOFTWARE, VERSION 1.7B
CEPHEID
SC2500N19-1
In Commercial Distribution

  • 07332940004880 ()
SC2500N19-1

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
SMART GBS AND SMARTCYCLE DX SYSTEM AND SOFTWARE, VERSION 1.7B
CEPHEID
SC2500N2-1
In Commercial Distribution

  • 07332940004866 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
SMART GBS AND SMARTCYCLE DX SYSTEM AND SOFTWARE, VERSION 1.7B
CEPHEID
SC2500N3-1
In Commercial Distribution

  • 07332940004842 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
SMART GBS AND SMARTCYCLE DX SYSTEM AND SOFTWARE, VERSION 1.7B
CEPHEID
SC2500N3-1R
In Commercial Distribution

  • 07332940004835 ()
SC2500N3-1R

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
SMART GBS AND SMARTCYCLE DX SYSTEM AND SOFTWARE, VERSION 1.7B
CEPHEID
SC2500N4-1
In Commercial Distribution

  • 07332940004804 ()
SC2500N4-1

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
SMART GBS AND SMARTCYCLE DX SYSTEM AND SOFTWARE, VERSION 1.7B
CEPHEID
SC2500N4-1R
In Commercial Distribution

  • 07332940004798 ()
SC2500N4-1R

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
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