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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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Acucy Calibration Device - 00742860100345

No Description
SEKISUI DIAGNOSTICS, LLC
1031
Not in Commercial Distribution

  • 00742860100345 ()


  • Optical laboratory instrument performance standard calibrator/control IVD, reusable

Acucy System - 00742860100338

No Description
SEKISUI DIAGNOSTICS, LLC
1039
Not in Commercial Distribution

  • 00742860100338 ()


  • Photometric/spectroscopic immunoassay analyser IVD

BD Veritor™ System CLIA-Waived Combo Pack - 00382902560715

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

Silaris Dock - B54010260

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

SCISSORS OPERATING 6" CRV. B/B TC - D9283001060

No Description
W.H. Holden, Inc.
30-0106
In Commercial Distribution

  • D9283001060 ()


  • Dental surgical scissors

SCISSORS OPERATING 6" STR B/B TC - D9283001030

No Description
W.H. Holden, Inc.
30-0103
In Commercial Distribution

  • D9283001030 ()


  • Dental surgical scissors

CARDINAL HEALTH - 10888439606034

OPEN HEART A B PACK
Cardinal Health 200, LLC
SCV43OHGL2
In Commercial Distribution

  • 50888439606032 ()
  • 10888439606034 ()
SCV43OHGL2

  • Cardiothoracic surgical procedure kit, medicated, single-use

CARDINAL HEALTH - 10888439604740

IUS IV START TRAY B
Cardinal Health 200, LLC
01-1698C
In Commercial Distribution

  • 50888439604748 ()
  • 10888439604740 ()
01-1698C

  • Vascular catheterization support/maintenance kit, non-medicated

CARDINAL HEALTH - 10888439604450

KIT, TOTAL KNEE B E165863
Cardinal Health 200, LLC
POMVKBNMH
In Commercial Distribution

  • 50888439604458 ()
  • 10888439604450 ()
POMVKBNMH

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

CARDINAL HEALTH - 10888439604412

KIT, TOTAL HIP B E159301
Cardinal Health 200, LLC
POMVTBNMM
In Commercial Distribution

  • 50888439604410 ()
  • 10888439604412 ()
POMVTBNMM

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