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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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STAT-Site Linearity Check - 00657498000113

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 B-HB Controls - 00657498000106

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

CHRONO-PAR - 00811476010147

Thrombin
CHRONO-LOG CORP
386
In Commercial Distribution

  • 00811476010147 ()


  • Platelet aggregation study IVD, reagent

CHRONO-PAR - 00811476010079

CHRONO-LUME
CHRONO-LOG CORP
395
In Commercial Distribution

  • 00811476010079 ()


  • Platelet aggregation study IVD, reagent

CHRONO-PAR - 00811476010062

ATP
CHRONO-LOG CORP
387
In Commercial Distribution

  • 00811476010062 ()


  • Platelet aggregation study IVD, reagent

CHRONO-PAR - 00811476010048

ADP
CHRONO-LOG CORP
384
In Commercial Distribution

  • 00811476010048 ()


  • Platelet aggregation study IVD, reagent

NA - ENTTCAM9S3D50601

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

NA - ENTTCAM9S3D43001

Scanbody 3D-Guide®
NT-Trading GmbH & Co. KG
CAM 9.S3D4.300
In Commercial Distribution

  • ENTTCAM9S3D43001 ()

  • CAM-Series 4,3 mm
CAM 9.S3D4.300

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

NA - ENTTCAM9S3D38001

Scanbody 3D-Guide®
NT-Trading GmbH & Co. KG
CAM 9.S3D3.800
In Commercial Distribution

  • ENTTCAM9S3D38001 ()

  • CAM-Series 3,8 mm
CAM 9.S3D3.800

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

NA - ENTTCAM9S3D33001

Scanbody 3D-Guide®
NT-Trading GmbH & Co. KG
CAM 9.S3D3.300
In Commercial Distribution

  • ENTTCAM9S3D33001 ()

  • CAM-Series 3,3 mm
CAM 9.S3D3.300

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