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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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Blake Silicone Drain, 24 FR round, hubless
Ethicon Inc.
2234
In Commercial Distribution

  • 20705031003627 ()
  • 10705031003620 ()
2234

  • Closed-wound drain, non-bioabsorbable
TRIAL, LINER, 0°, 28mm, GROUP 0
Exactech, Inc.
131-28-01
In Commercial Distribution

  • 10885862022615 ()

  • Liner Face Angle
  • GROUP 0
  • Lumen/Inner Diameter: 28 Millimeter
  • 0 Degree Angle
131-28-01

  • Acetabulum prosthesis trial, prefabricated, reusable
VIRTUGUIDE 0 RAC ROTATION- 0° - UNI
CROSSROADS EXTREMITY SYSTEMS
VIRTUGUIDE 0 RAC ROTATION- 0° - UNI
In Commercial Distribution

  • 00810112598476 ()
380002LR-NSPKG

  • Orthopaedic instrument surgical connector
L6L TI-ORTHOS 22 -10/0/0
ORMCO CORPORATION
449-2126
In Commercial Distribution

  • 20889989003097 ()
  • 00889989003093 ()

  • Slot size 022, Torque -10, Angulation 0, Rotation 0


  • Orthodontic tube
L6R TI-ORTHOS 22 -10/0/0
ORMCO CORPORATION
449-2026
In Commercial Distribution

  • 20889989003059 ()
  • 00889989003055 ()

  • Slot size 022, Torque -10, Angulation 0, Rotation 0


  • Orthodontic tube
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
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