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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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BD Trucount™ Tubes
Becton, Dickinson And Company
340334
In Commercial Distribution

  • 00382903403349 ()
  • 80382903403345 ()
340334

  • Multiple mature lymphocyte cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow)
  • White blood cell count IVD, reagent
No Description
SEKISUI DIAGNOSTICS, LLC
1031
Not in Commercial Distribution

  • 00742860100345 ()


  • Optical laboratory instrument performance standard calibrator/control IVD, reusable
No Description
SEKISUI DIAGNOSTICS, LLC
1039
Not in Commercial Distribution

  • 00742860100338 ()


  • Photometric/spectroscopic immunoassay analyser IVD
OSOM Ultra Flu Aspirate 25T Kit
SEKISUI DIAGNOSTICS, LLC
1007
In Commercial Distribution

  • 00742860100239 ()
  • 10742860100236 ()
1007

  • Nasopharyngeal aspirate container IVD
BD Veritor™ System CLIA-Waived Combo Pack Contains: 2xBD Veritor ™ System for Rapid Detection of Flu A+B, CLIA-Wavied Kits (Cat. No. 256045) 1xBD Veritor ™ System Reader (Cat. No. 256055)
BECTON, DICKINSON AND COMPANY
256071
Not in Commercial Distribution

  • 00382902560715 ()
256071

  • Multiple-genus respiratory virus antigen IVD, kit, rapid ICT, clinical
The Silaris Dock is an electronic module which executes in vitro diagnostic tests on compatible Silaris Test Cassettes. It consists of an electro-mechanical interface to a single Test Cassette. The Dock contains all electrical systems, controls and logic necessary to orchestrate in-vitro diagnostic tests within the inserted Test Cassette.
MESA BIOTECH, INC.
1026
In Commercial Distribution

  • B54010260 ()
1026

  • Thermal cycler nucleic acid amplification analyser IVD, point-of-care
No Description
W.H. Holden, Inc.
30-0106
In Commercial Distribution

  • D9283001060 ()


  • Dental surgical scissors
No Description
W.H. Holden, Inc.
30-0103
In Commercial Distribution

  • D9283001030 ()


  • Dental surgical scissors
OPEN HEART PACK B ILM
Cardinal Health 200, LLC
SCVCGOHIL4
In Commercial Distribution

  • 50195594512437 ()
  • 10195594512439 ()
SCVCGOHIL4

  • Cardiothoracic surgical procedure kit, non-medicated, single-use
TOTAL KNEE A & B PACK
MEDLINE INDUSTRIES, INC.
DYNJ86860
In Commercial Distribution

  • 40195327685363 ()
  • 10195327685362 ()
DYNJ86860

  • General surgical procedure kit, non-medicated, single-use
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