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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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L6L TI-ORTHOS 18 -10/0/0
ORMCO CORPORATION
448-2126
In Commercial Distribution

  • 20889989002854 ()
  • 00889989002850 ()

  • Slot size 018, Torque -10, Angulation 0, Rotation 0


  • Orthodontic tube
L6R TI-ORTHOS 18 -10/0/0
ORMCO CORPORATION
448-2026
In Commercial Distribution

  • 20889989002816 ()
  • 00889989002812 ()

  • Slot size 018, Torque -10, Angulation 0, Rotation 0


  • Orthodontic tube
STAT-Site® Diluent is intended to be used with the STAT-Site® M β-HB Test Strips or KetoSite® Test Cards to dilute specimens containing high levels of β-hydroxybutyrate into the test range of 0 – 2 mM. Additionally, the diluent helps to eliminate possible matrix effects caused by interfering substances such as acetoacetate.
STANBIO LABORATORY, L.P.
202000
In Commercial Distribution

  • 00657498000120 ()
202000

  • Buffered sample diluent IVD, manual
The STAT-Site® Linearity Check is intended to be used to perform a linearity evaluation of the STAT-Site® Mβ-HB Test Strips /KetoSite® Test Cards by making a series of dilutions using STAT-Site® Diluent (Catalog No. 202000). Both the STAT-Site® Mβ-HB Test Strips and KetoSite® Test Cards are used in the measurement of β-hydroxybutyrate with the STAT-Site® Mβ-HB and STAT-Site® Meter.
STANBIO LABORATORY, L.P.
303500
In Commercial Distribution

  • 00657498000113 ()
303500

  • Beta-hydroxybutyrate IVD, calibrator
STAT-Site® Controls are intended to be used to verify the procedural reliability of the assay for β-hydroxybutyrate using STAT-Site® Mβ-HB Meter and Test Strips.
STANBIO LABORATORY, L.P.
303000
In Commercial Distribution

  • 00657498000106 ()
303000

  • Beta-hydroxybutyrate IVD, control
Thrombin
CHRONO-LOG CORP
386
In Commercial Distribution

  • 00811476010147 ()


  • Platelet aggregation study IVD, reagent
CHRONO-LUME
CHRONO-LOG CORP
395
In Commercial Distribution

  • 00811476010079 ()


  • Platelet aggregation study IVD, reagent
ATP
CHRONO-LOG CORP
387
In Commercial Distribution

  • 00811476010062 ()


  • Platelet aggregation study IVD, reagent
ADP
CHRONO-LOG CORP
384
In Commercial Distribution

  • 00811476010048 ()


  • Platelet aggregation study IVD, reagent
Scanbody 3D-Guide®
NT-Trading GmbH & Co. KG
CAM 9.S3D5.060
In Commercial Distribution

  • ENTTCAM9S3D50601 ()

  • CAM-Series 5,0 mm
CAM 9.S3D5.060

  • Dental implant abutment analog, intraoral-scanning, single-use
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