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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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Pylo Lancing Device
Prevounce Health, Inc
GL1-LCT
In Commercial Distribution

  • 00860011521235 ()


  • Manual blood lancing device, reusable
Pylo Blood Glucose Test Strip
Prevounce Health, Inc
GL1-STP-50
In Commercial Distribution

  • 00860011521228 ()


  • Blood glucose/blood pressure monitoring system, home-use
Pylo Blood Glucose Meter Device GL1-LTE
Prevounce Health, Inc
GL1-LTE
In Commercial Distribution

  • 00860011521204 ()


  • Blood glucose/blood pressure monitoring system, home-use
5-Strip HCG Pregnancy Tests, 25-Strip LH-Ovulation Test, and 30 Plastic Urine Cups
VIVOSENS INC.
VWHL25V1
In Commercial Distribution

  • 10860011489167 ()
  • 00860011489160 ()
  • 20860011489164 ()


  • Natural conception assistance kit
Cesium-131 Implant Devices combined with MRI Markers will be used to facilitate the anatomical location of seeds after they have been implanted in the prostate of a patient with confirmed prostatic malignancy. The PL-8 device is preloaded strands with Markers in 18G needles.
GT MEDICAL TECHNOLOGIES, INC.
PL-8
In Commercial Distribution

  • 00860011485469 ()
  • M748PL80 ()


  • Prostate brachytherapy system applicator, manual
No Description
GT MEDICAL TECHNOLOGIES, INC.
PL-7
In Commercial Distribution

  • 00860011485452 ()
  • M748PL70 ()


  • Prostate brachytherapy system applicator, manual
No Description
GT MEDICAL TECHNOLOGIES, INC.
PL-5M
In Commercial Distribution

  • 00860011485445 ()
  • M748PL5M0 ()


  • Manual brachytherapy source, permanent implant
No Description
GT MEDICAL TECHNOLOGIES, INC.
PL-4NS
In Commercial Distribution



  • Manual brachytherapy source, permanent implant
No Description
GT MEDICAL TECHNOLOGIES, INC.
PL-4
In Commercial Distribution

  • 00860011485421 ()
  • M748PL40 ()


  • Manual brachytherapy source, permanent implant
No Description
GT MEDICAL TECHNOLOGIES, INC.
PL-3
In Commercial Distribution

  • 00860011485414 ()
  • M748PL30 ()


  • Manual brachytherapy source, permanent implant
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