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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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Resin Based Dental Cement
TEMREX CORPORATION
7760
In Commercial Distribution

  • 00850015110054 ()


  • Dental acrylic resin
DENTAL CEMENT
TEMREX CORPORATION
7790 KIT
In Commercial Distribution

  • 00850015110047 ()


  • Zinc oxide eugenol dental cement
POWDER FOR MIXING WITH CEMENT LIQUID
TEMREX CORPORATION
330 25gm. White
In Commercial Distribution

  • 00850015110030 ()


  • Zinc oxide eugenol dental cement
LIQUID FOR MIXING WITH DENTAL CEMENT POWDER
TEMREX CORPORATION
310 1oz.
In Commercial Distribution

  • 00850015110023 ()


  • Zinc oxide eugenol dental cement
No Description
O'well
OW-BL-26g-300
In Commercial Distribution

  • 00850015109034 ()


  • Blood glucose/blood pressure monitoring system, home-use
No Description
O'well
OW-BL-28g-300
In Commercial Distribution

  • 00850015109027 ()


  • Blood glucose/blood pressure monitoring system, home-use
No Description
O'well
OW-BL-30g-300
In Commercial Distribution

  • 00850015109010 ()


  • Blood glucose/blood pressure monitoring system, home-use
No Description
O'well
OW-BL-33g-300
In Commercial Distribution

  • 00850015109003 ()


  • Blood glucose/blood pressure monitoring system, home-use
The Spectrum Solutions BioMAX Specimen Collection device consists of a plastic tube designed for the collection of human saliva samples, a funnel, a cap with a stem flare, and a fluid chamber containing Spectrum’s inactivating media. Sample collection is conducted under the supervision of a Health care provider. The user deposits their saliva into the collection tube with the aid of the attached funnel, the user removes the funnel and replaces it with the cap. Upon twisting and closing the cap, the stabilizing solution is released into the tube and mixed with the saliva.
Spectrum Solutions L.L.C.
SDNA 1000
In Commercial Distribution

  • 00850015033001 ()
  • 10850015033008 ()
2019162

  • Oral/respiratory tract specimen container IVD, additive/medium
No Description
MEDIBIO USA LLC
TD-4277
In Commercial Distribution

  • 00850014981051 ()


  • Glucose IVD, kit, electrometry
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