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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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NOVA 5/5+ Analyzer w/ Printer( No Acc Pack)
NOVA BIOMEDICAL CORPORATION
5
In Commercial Distribution

  • 10385480141564 ()
  • 00385480141567 ()
14156

  • Metabolic profile clinical chemistry analyser IVD, portable, semi-automated
PABLO is a modern therapy device for the rehabilitation of patients suffering from motoric dysfunctions; it is primarily used for neurological rehabilitation purposes.
tyromotion GmbH
5
In Commercial Distribution

  • 09120077180151 ()


  • Virtual-display rehabilitation system, non-supportive, clinical
The TYMO system is a modern monitoring and therapy device for the rehabilitation of patients suffering from motoric dysfunctions; it is primarily used for neurological rehabilitation purposes.
tyromotion GmbH
5
In Commercial Distribution

  • 09120077180045 ()


  • Virtual-display rehabilitation system, non-supportive, clinical
KermaX Product family is designed to be installed in diagnostic x-ray units and is intended to be used for the measurement of Dose Area Product (DAP)/ DAP rate, exposure time.
IBA Dosimetry GmbH
5
In Commercial Distribution

  • EIBA120131281 ()
  • EIBA120131280 ()
120-131OEM CAN

  • Diagnostic x-ray system quality assurance device
No Description
Heine Optotechnik GmbH & Co. KG
5
In Commercial Distribution

  • 04053755200238 ()
F-000.22.105

  • Laryngoscope blade, reusable
No Description
QIAGEN GmbH
5
In Commercial Distribution

  • 04053228045809 ()
62724

  • Nucleic acid extraction/isolation kit IVD
No Description
icometrix NV
5
In Commercial Distribution

  • B621ICOBRAIN50 ()


  • Radiology DICOM image processing application software
CueSee® Coag is an unassayed quality control material intended to verify the precision of prothrombin time (PT), International Normalized Ratio (INR), activated clotting time (ACT) and/or activated partial thromboplastin time (aPTT) measurements on coagulation analyzers in the clinically relevant range. For laboratory and near-patient (point-of-care) testing by healthcare professionals.
Eurotrol B.V.
5
In Commercial Distribution

  • 08718734962816 ()
  • 08718734962762 ()
340.005.005

  • Multiple coagulation factor IVD, control
ProOcular Daily Disposable Contact Lens Power -5
CARLSBAD TECHNOLOGY INC.
-5
Not in Commercial Distribution

  • 40816816880532 ()
  • 30816816880535 ()
  • 10816816880531 ()
  • 00816816880534 ()


  • Soft corrective contact lens, daily-disposable
No Description
Everly Health, Inc.
5
In Commercial Distribution

  • G7324001 ()


  • Urine specimen collection kit IVD
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