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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
73400
In Commercial Distribution

  • 00853383006073 ()


  • Dental amalgam
No Description
Wykle Research, Inc
73300
In Commercial Distribution

  • 00853383006066 ()


  • Dental amalgam
No Description
Wykle Research, Inc
73100
In Commercial Distribution

  • 00853383006042 ()


  • Dental amalgam
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 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
Fat microsizing unit.
Syntr Health Technologies, Inc
90-1006
In Commercial Distribution

  • 00860005496730 ()
90-1006

  • Autologous adipose tissue noninvasive processing set
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