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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WBP Home A BT (BP3MX1-3C) with Universal Label for USA/EU/CA markets
MICROLIFE USA, INC.
CRO-BP3MX1-3C1
In Commercial Distribution

  • 04719003315085 ()
  • 14719003315082 ()
  • 24719003315089 ()
  • 34719003315086 ()


  • Arrythmia-detection sphygmomanometer
FLEX Monoclonal Mouse Anti-Human CA 125 Clone M11 Ready-to-Use (Dako Autostainer/ Autostainer Plus)
AGILENT TECHNOLOGIES SINGAPORE PTE LTD
IS701
In Commercial Distribution

  • 05700572030973 ()

  • 20-30 Tests


  • Cancer antigen 125 (CA125) IVD, antibody
For the calibration of Na+, K+, Cl-, Ca++, tCO2, BUN, Glucose and Creatinine.
Diamond Diagnostics Inc.
BK-465910D
In Commercial Distribution

  • 00811403011575 ()


  • Multiple electrolyte IVD, calibrator
For the calibration of Na+, K+, Cl-, Ca++, tCO2, BUN, Glucose and Creatinine.
Diamond Diagnostics Inc.
BK-465909D
In Commercial Distribution

  • 00811403011568 ()


  • Multiple electrolyte IVD, calibrator
For the calibration of Na+, K+, Cl-, Ca++, tCO2, BUN, Glucose and Creatinine.
Diamond Diagnostics Inc.
BK-465908D
In Commercial Distribution

  • 00811403011551 ()


  • Multiple electrolyte IVD, calibrator
NOVA CONTROL 3 Na+,K+,Cl-,Ca++,GLU,BUN, TCa,Mg++,Li+,pH
NOVA BIOMEDICAL CORPORATION
3
In Commercial Distribution

  • 00385480186544 ()
  • 00385489186545 ()
18654

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
Wipe Down Body Wedge Set, Rounded (1 each-BPW04R/ 1 each-BPW04LR) - 10/ST/CA
PRIMO INC
BPW10R
In Commercial Distribution

  • 10810006683841 ()
  • 00810006683844 ()
BPW10R

  • Freestanding patient positioner, reusable
TITAN-Periodontal Probe # CP15"North Ca" graduated; 1-2...-14-15 mm COMFORT | SL | single ended
devemed GmbH
02-2525-40 CT
In Commercial Distribution

  • 04061644039623 ()


  • Periodontal probe, reusable
TITAN-Periodontal Probe # CP15"North Ca" graduated; 1-2...-14-15 mm F-LINE | SL | single ended
devemed GmbH
2525-40 FT
In Commercial Distribution

  • 04061644039616 ()


  • Periodontal probe, reusable
Series 1, 500 DT, Triple CA, 1600mm, 1450mm, 1300mm, (Normal 3P SADual yoke
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706009439 ()
C15T76533R

  • Operating room light
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