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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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Quadric Biomed, LLC
KSG10.5
In Commercial Distribution

  • D985KSG1050 ()


  • Dental implant system
The product is intended for the quantitative in vitro determination of Lithium in serum.
RANDOX LABORATORIES LIMITED
LM4005
In Commercial Distribution

  • 05055273209143 ()
LM4005

  • Lithium therapeutic drug monitoring IVD, reagent
MultiPurpose Instrument Cleaner Polisher and Cart Washer Agent
METREX RESEARCH, LLC
10-8130
In Commercial Distribution

  • 00615375005767 ()

  • Total Volume: 30 Gallon


  • Medical device-decontamination agent
MultiPurpose Instrument Cleaner Polisher and Cart Washer Agent
METREX RESEARCH, LLC
10-8115
In Commercial Distribution

  • 00615375005750 ()

  • Total Volume: 15 Gallon


  • Medical device-decontamination agent
MultiPurpose Instrument Cleaner Polisher and Cart Washer Agent
METREX RESEARCH, LLC
10-8150
In Commercial Distribution

  • 00615375005743 ()

  • Total Volume: 5 Gallon


  • Medical device-decontamination agent
MultiPurpose Instrument Cleaner Polisher and Cart Washer Agent
METREX RESEARCH, LLC
10-8100
In Commercial Distribution

  • 00615375005736 ()

  • Total Volume: 1 Gallon


  • Medical device-decontamination agent
Revascularization Device
Micro Therapeutics, Inc.
SFR2-4-40
In Commercial Distribution

  • 00847536003323 ()

  • Outer Diameter: 4 Millimeter
  • Length: 50 Millimeter
  • Usable Length,40,Millimeter;Push Wire Length,180,Centimeter;
SFR2-4-40

  • Bare-metal intracranial vascular stent
F2 CATHETER FG PKG
Bayer Healthcare LLC
109400-001
In Commercial Distribution

  • 00616258003955 ()

  • Catheter Gauge: 6 French
109400

  • Thrombectomy suction catheter
Radiation therapy QA device.
SUN NUCLEAR CORP.
1174300Z
In Commercial Distribution

  • 05060608880140 ()
11740000Z

  • Accelerator system quality assurance device
Radiation therapy QA device.
SUN NUCLEAR CORP.
1137000-0Z
In Commercial Distribution

1137000-0Z

  • Solid-state-semiconductor radiation measuring probe
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