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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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Disposable Medical Face Mask
Shenzhen 3Nod Electronics Co., Ltd.
17.5cm*9.5cm
In Commercial Distribution

  • 06922634100007 ()
  • 06922634100106 ()


  • Surgical/medical face mask, single-use
Face mask is made of fabric material, either non-woven or woven
PHU TUONG GARMENT COMPANY LIMITED
PT05
In Commercial Distribution

  • 28938533047055 ()
  • 18938533047058 ()


  • Public face mask, single-use
No Description
Qingdao Likangyuan Medical Device Co.,Ltd.
Flat ear loop
In Commercial Distribution

  • 06972535040001 ()


  • Public face mask, single-use
Custom first aid kit containing sufficient first aid items needed to help treat minor injuries for twenty-five people
Acme United Corporation
223-U/RAC
In Commercial Distribution

  • 00092265223317 ()
223-U/RAC

  • First aid kit, medicated
FETALSCREEN™ is a Qualitative Screening Test for RhD (Rho) positive fetal red blood cells in the maternal circulation.
ALBA BIOSCIENCE LIMITED
Z488
In Commercial Distribution

  • 10758750006144 ()


  • Foeto-maternal haemorrhage/Kleihauer test IVD, control
The Access SARS-CoV-2 IgG II Calibrators are intended to calibrate the Access SARS-CoV-2 IgG II assay for the in vitro semi-quantitative and qualitative detection of SARS-CoV-2 IgG antibodies in human plasma (lithium heparin, dipotassium EDTA, tripotassium EDTA, and sodium citrate) for use on the Access Immunoassay Systems only. The Access SARS-CoV-2 IgG II calibrators are only for use under the Food and Drug Administration's Emergency Use Authorization.
Beckman Coulter, Inc.
C69058
In Commercial Distribution

  • 15099590742751 ()
C69058

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator
Universal Densah Bur Holder is a holder for the ZGO Densah Burs and ZGO Guided Keys, ZGO Tapered Pilot Drill
VERSAH, LLC
ZBLK
In Commercial Distribution

  • 00850017652781 ()


  • Surgical instrument interim-placement holder, reusable
First Aid Kit intended for administering aid in the workplace to a person with an eye injury. Managed First Aid.
REDICARE LLC
Eye Wound Kit
In Commercial Distribution

  • B70901020710 ()
0102071

  • First aid kit, medicated
An in vitro diagnostic, a time resolved fluorescence lateral flow immunoassay for the qualitative detection of nucleocapsid antigen from SARS-CoV-2.
NANO-DITECH CORPORATION
TF-8150
In Commercial Distribution

  • 10895160002790 ()
  • 00895160002793 ()


  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
The UroShield driver is an electronic unit intended to drive an accessory (Ultrasonic Actuator) that creates surface acoustic waves on Urinary catheter to prevent bacterial adhesion and minimized risk of CAUTI (Catheter Associated Urinary Tract Infections).
NANOVIBRONIX INC.
3.0
In Commercial Distribution

  • 07290103420277 ()
10-800-0003

  • Urinary catheter ultrasonic bacterial adhesion inhibition system
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