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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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No Description
Wykle Research, Inc
73000
In Commercial Distribution

  • 00853383006035 ()


  • Dental amalgam
No Description
Wykle Research, Inc
61133-03
In Commercial Distribution

  • 00853383006028 ()


  • Dental amalgam
No Description
Wykle Research, Inc
61143-03
In Commercial Distribution

  • 00853383006011 ()


  • Dental amalgam
No Description
Wykle Research, Inc
61153-03
In Commercial Distribution

  • 00853383006004 ()


  • Dental amalgam
The Verigene® Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) performed using the sample-to-result Verigene® System is a qualitative, multiplexed in vitro diagnostic test for the simultaneous detection and identification of potentially pathogenic gram-positive bacteria which may cause bloodstream infection (BSI).
NANOSPHERE, INC.
20-009-018
Not in Commercial Distribution

  • 00857573006218 ()


  • Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry
The STAT-Site® Mß-HB Meter is a dedicated reflectance photometer designed to accept only STAT-Site® Mß-HB CODE Keys and STAT-Site® Mß-HB Test Strips. This test system is intended or the quantitative determination of ß-hydroxybutyrate in serum or plasma.
STANBIO LABORATORY, L.P.
401020
In Commercial Distribution

  • 00657498000731 ()
401020

  • Single-channel clinical chemistry analyser IVD, point-of-care
The STAT-Site® M Hgb Meter is a dedicated reflectance photometer designed to accept only STAT-Site® M Hgb CODE Keys and STAT-Site® M Hgb Test Cards. This test system is intended for the quantitative determination of hemoglobin in the whole blood of adults, infants, and children in a physician’s office or other professional point-of-care setting.
STANBIO LABORATORY, L.P.
901010
Not in Commercial Distribution

  • 00657498000175 ()
901010

  • Haemoglobin analyser IVD, point-of-care
The Stanbio STAT-Site® MHgb Test Kit is intended for the quantitative determination of hemoglobin in whole blood using the Stanbio STAT-Site® MHgb Meter. The STAT-Site® MHgb Test may be used with adults, infants, and children in a physician’s office or other professional point-of-care setting.
STANBIO LABORATORY, L.P.
901025
Not in Commercial Distribution

  • 00657498000151 ()
  • 00657498001820 ()
901025

  • Haemoglobin analyser IVD, point-of-care
saremco print CROWNTEC is a light-curing, flowable polymer based on methacrylic acid ester for production of 3D-printed permanent crowns, inlays, onlays, veneers, temporary crowns & bridges, and artificial teeth (i.e., complete or partial dentures).
Saremco Dental AG
sw
In Commercial Distribution

  • D93180661 ()
8066

  • Dental appliance fabrication material, resin
saremco print CROWNTEC is a light-curing, flowable polymer based on methacrylic acid ester for production of 3D-printed permanent crowns, inlays, onlays, veneers, temporary crowns & bridges, and artificial teeth (i.e., complete or partial dentures).
Saremco Dental AG
B1
In Commercial Distribution

  • D93180651 ()
8065

  • Dental appliance fabrication material, resin
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