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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Handpiece, ProStyle E Contra-Angle, 1:5 ratio, Push Button Friction Grip, Classic
LARES RESEARCH
CA,ProStyle E, 1:5,PB,FG, Classic
Not in Commercial Distribution

  • D950132230 ()
13223

  • Dental surgical power tool motorized handpiece/set, electric
Handpiece, ProStyle E Contra-Angle, 1:1 ratio, Push Button Latch
LARES RESEARCH
CA, ProStyle E, 1:1, PB,Latch, Micro
Not in Commercial Distribution

  • D950132220 ()
13222

  • Dental surgical power tool motorized handpiece/set, electric
Handpiece, ProStyle E Contra-Angle, 1:5 ratio, Push Button Friction Grip
LARES RESEARCH
CA,ProStyle E, 1:5,PB,FG, Micro
Not in Commercial Distribution

  • D950132210 ()
13221

  • Dental surgical power tool motorized handpiece/set, electric
No Description
Slmp, LLC
(BTO) Sample TAG-72/CA 72-4 (B72.3) Antibody (2ml)
In Commercial Distribution

  • 00810170552595 ()
SAM-MM137-2

  • Tumour-associated glycoprotein-72 (TAG72) IVD, antibody
No Description
GLOBAL SURGICAL CORPORATION
M 528RF2
In Commercial Distribution

  • 00810040251344 ()


  • General-purpose surgical microscope
The RAPIDPoint 500 system is designed for professional use in a point-of-care or laboratory environment. This system tests blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples. The following parameters are tested: pH, pCO2, pO2, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, FO2Hb, FCOHb, FMetHb, FHHb, nBili
Siemens Healthcare Diagnostics Inc.
10492730
In Commercial Distribution

  • 00630414589169 ()
10492730

  • Blood gas/haemoximetry analyser IVD, point-of-care
CueSee® VeriSTAT QC - Level 3 is an assayed aqueous quality control material for professional use in the verification of the precision and accuracy of the Abbott i -STAT® POCT analyzer. It is intended that CueSee® VeriSTAT QC - Level 1 should be used in the periodic verification of the precision, accuracy of the Abbott i -STAT POCT analyzer when measuring: pH, pO2, pCO2, Na+, K+, Ca++, Cl -, Glucose, Lactate, Urea, Creatinine, TCO2 and Hematocrit.
Eurotrol B.V.
Level 3
In Commercial Distribution

  • 08718734961529 ()
  • 08718734961499 ()
221.003.010

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
CueSee® VeriSTAT QC - Level 2 is an assayed aqueous quality control material for professional use in the verification of the precision and accuracy of the Abbott i -STAT® POCT analyzer. It is intended that CueSee® VeriSTAT QC - Level 1 should be used in the periodic verification of the precision, accuracy of the Abbott i -STAT POCT analyzer when measuring: pH, pO2, pCO2, Na+, K+, Ca++, Cl -, Glucose, Lactate, Urea, Creatinine, TCO2 and Hematocrit.
Eurotrol B.V.
Level 2
In Commercial Distribution

  • 08718734961512 ()
  • 08718734961482 ()
221.002.010

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
CueSee® VeriSTAT QC - Level 1 is an assayed aqueous quality control material for professional use in the verification of the precision and accuracy of the Abbott i -STAT® POCT analyzer. It is intended that CueSee® VeriSTAT QC - Level 1 should be used in the periodic verification of the precision, accuracy of the Abbott i -STAT POCT analyzer when measuring: pH, pO2, pCO2, Na+, K+, Ca++, Cl -, Glucose, Lactate, Urea, Creatinine, TCO2 and Hematocrit.
Eurotrol B.V.
Level 1
In Commercial Distribution

  • 08718734961505 ()
  • 08718734961475 ()
221.001.010

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
CueSee® VeriSTAT LVM is an assayed aqueous blood gas, electrolyte and metabolite control material suitable for calibration verification of the Abbott i -STAT® POCT analyzer. It is intended that CueSee® VeriSTAT LVM should be used in the periodic verification of the precision and accuracy of the Abbott i -STAT POCT analyzer when measuring: pH, pO2, pCO2, Na+, K+, Ca++, Cl -, Glucose, Lactate, Urea, Creatinine, TCO2 and Hematocrit. A box of CueSee® VeriSTAT LVM contains 5 levels of control material: CueSee® VeriSTAT LVM Level 1 - 08718734961413 CueSee® VeriSTAT LVM Level 2 - 08718734961420 CueSee® VeriSTAT LVM Level 3 - 08718734961437 CueSee® VeriSTAT LVM Level 4 - 08718734961444 CueSee® VeriSTAT LVM Level 5 - 08718734961451
Eurotrol B.V.
220.000.005
In Commercial Distribution

  • 08718734961468 ()


  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
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