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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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SmartCycler Dx System - 07332940004606

SMART GBS AND SMARTCYCLE DX SYSTEM AND SOFTWARE, VERSION 1.7B
CEPHEID
SC2500N1-1
In Commercial Distribution

  • 07332940004606 ()
SC2500N1-1

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

SmartCycler Dx System - 07332940004583

SMART GBS AND SMARTCYCLE DX SYSTEM AND SOFTWARE, VERSION 1.7B
CEPHEID
SC2500N12-1
In Commercial Distribution

  • 07332940004583 ()
SC2500N12-1

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

SmartCycler Dx System - 07332940004569

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

SmartCycler Dx System - 07332940004545

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

SmartCycler Dx System - 07332940004538

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

SmartCycler Dx System - 07332940004521

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® - 15420045510470

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

Wirion - 10850000491882

Wirion Embolic Protection System
Cardiovascular Systems, Inc.
WRN-D6
In Commercial Distribution

  • 10850000491882 ()

  • Deployed Filter Unit Length 22.5 mm
  • Deployed Filter Diameter 3.5-6.0 mm
  • Distal tip to strain relief (usable length) - delivery 144 cm
  • Rapid Exchange (RX) length - delivery 38 cm
  • Maximum catheter diameter - delivery 1.14 mm
  • Distal tip to strain relief (usable length) - retrieval 145 cm
  • Rapid Exchange (RX) length - retrieval 31 cm
  • Maximum catheter diameter - retrieval 1.67 mm
7-10078-01

  • Embolic protection filtering guidewire

Diamondback Coronary - 10850000491363

DIAMONDBACK CORONARY, CLASSIC CROWN, 1.25MM, 135CM SHAFT
Cardiovascular Systems, Inc.
DBEC-125
In Commercial Distribution

  • 10850000491363 ()

  • Crown Diameter: 1.25mm
  • nose length: 5mm
  • shaft length: 135cm
  • guidewire size OD: 0.012 inches
  • low speed: 80krpm
  • high speed: 120krpm
  • Crown Type: Classic
  • Max OD: 0.052 inches
  • Intro Sheath: 6Fr
7-10060-02

  • Mechanical atherectomy system, coronary, line-powered

Diamondback Coronary - 10850000491356

DIAMONDBACK CORONARY, CLASSIC CROWN, 1.25MM, 135CM SHAFT
Cardiovascular Systems, Inc.
DBEC-125
In Commercial Distribution

  • 10850000491356 ()

  • Crown diameter: 1.25mm
  • nose length: 5mm
  • shaft length: 135cm
  • guidewire size OD: 0.012 inches
  • low speed: 80 krpm
  • high speed: 120 krpm
  • Max OD: 0.0495 inches
  • Intro Sheath: 6 Fr
  • Crown Type: Classic
7-10060-01

  • Mechanical atherectomy system, coronary, line-powered
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