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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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SyntrFuge System - 00860005496709

Fat microsizing unit.
Syntr Health Technologies, Inc
90-1001
In Commercial Distribution

  • 00860005496709 ()
90-1001

  • Autologous adipose tissue noninvasive processing set

STAT-Site M B-HB Code Key - 00657498000731

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

STAT-Site M Hgb Code Key - 00657498000175

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

STAT-Site M Hgb Cards - 00657498000151

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

ANA 2000 Capsules 2 Spill 50 count - 00853383006998

No Description
Wykle Research, Inc
1173100
In Commercial Distribution

  • 00853383006998 ()


  • Dental amalgam

ANA 2000 Capsules 1 Spill 50 count - 00853383006981

No Description
Wykle Research, Inc
1173000
In Commercial Distribution

  • 00853383006981 ()


  • Dental amalgam

Original D Ex Fast Jar - 00853383006943

No Description
Wykle Research, Inc
193
In Commercial Distribution

  • 00853383006943 ()


  • Dental amalgam

Original D Powder 4 min jar - 00853383006936

No Description
Wykle Research, Inc
194
In Commercial Distribution

  • 00853383006936 ()


  • Dental amalgam

ANA 70 Capsules 3 Spill 450 count - 00853383006912

No Description
Wykle Research, Inc
1113500
In Commercial Distribution

  • 00853383006912 ()


  • Dental amalgam

ANA 70 Capsules 2 Spill 450 count - 00853383006905

No Description
Wykle Research, Inc
1113400
In Commercial Distribution

  • 00853383006905 ()


  • Dental amalgam
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