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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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Walgreens Motion Sickness Glasses 1CT - Walgreens Motion Sickness Glasses help alleviate symptoms associated with motion sickness based on the theory of synchronizing your visual system with the motion of the vehicle. The level of blue liquid in the glasses varies according to motion, creating an artificial horizon in your vision to help re-synchronize your eyes with your sense of balance. These motion sickness glasses are drug free and are suitable for both adults and children.
WALGREEN CO.
486529
In Commercial Distribution

  • 00311917123738 ()
  • 10311917123735 ()


  • Spectacle frame
The HPX Polarization Measurement Station is a low-field nuclear magnetic resonance (NMR) spectrometer tuned to detect xenon Xe 129 signal. The HPX Polarization Measurement Station accomplishes the following: Ensures that the amount of XENOVIEW™ in the XENOVIEW™ Dose Delivery Bag is sufficient for measurement; Calculates the Dose Equivalent (DE) value prior to administration to a patient; Stores a XENOVIEW™ Dose Delivery Bag filled with XENOVIEW™ in a static magnetic field.
Polarean, Inc.
Rev. D
In Commercial Distribution

  • 00850045949020 ()
42881

  • Lung MRI xenon hyperpolarization system
The COVID-19 total Ab is designed for the qualitative and quantitative measurement of anti-coronavirus IgG and IgM in human serum and plasma (Li-heparinized, EDTA, and citrate) by fluorescence immunoassay (FIA) using the FREND™ System.
NanoEnTek, Inc.
FREND COVID-19 total Ab
In Commercial Distribution

  • 08809317540924 ()
FRCOA 020

  • SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, fluorescent immunoassay
Mini First Aid Kit in a plastic case containing: Adhesive Plastic Bandages, 3/4" x 3" (5), Adhesive Plastic Bandages, 3/8" x 1-1/2" (4), BZK Antiseptic Wipe, Sterile Gauze Pad, 2" x 2", Sting Relief Wipe
Acme United Corporation
90101
In Commercial Distribution

  • 00073577901018 ()
90101

  • First aid kit, medicated
Handheld LED Light Therapy Device. Treatment heads, available in Blue (415nm) or Red (633nm), help to mitigate a variety of skin conditions. There are 8 LEDs to provide a treatment area of 4 sq. cm. Batery powered with a charger
Medtek Lighting Corporation
7000C2
In Commercial Distribution

  • B3437000C21 ()

  • Area/Surface Area: 4 Square centimeter


  • Blue/red/infrared phototherapy lamp
Handheld LED Light Therapy Device. Treatment heads, available in Red (633nm), Blue (415nm) and Infrared (850nm), help to mitigate a variety of skin conditions. There are 48 LEDs to provide a treatment area of 26 square cm. Battery powered with a charger.
Medtek Lighting Corporation
7000C
In Commercial Distribution

  • B3437000C1 ()


  • Blue/red/infrared phototherapy lamp
Qualitative detection of nucleocapsid protein antigen from SARSCoV-2 in direct nasopharyngeal swab (NP) specimens from individuals who are suspected of COVID-19 by their healthcare provider within the first six days of symptom onset. Emergency use of this test is limited to authorized laboratories.
Genbody Inc.
COVAG025-U
In Commercial Distribution

  • 08800076700437 ()
  • 08800076700475 ()
COVAG025-U

  • SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical
The Osteon Precision Milled Suprastructure is indicated for attachment to dental abutments in the treatment of partially or fully edentulous jaws for the purpose of restoring chewing function. The Osteon Precision Milled Suprastructures are intended for attachment to a minimum of two (2) abutments.
IMPLANT SOLUTIONS PTY LTD
1
In Commercial Distribution

  • D102BAR0 ()


  • Dental implant suprastructure, permanent, custom-made
  • Dental implant suprastructure, temporary, custom-made
Tin First Aid Kit Item#3556 Features: Retro tin case Small enough to store in a glove compartment, backpack, purse or bag Includes 4 latex-free bandages, 2 snip bandages, 2 antiseptic towelettes, 2 first aid cream packets, a hand sanitizer packet and a 2" x 3" adhesive pad
EVANS MANUFACTURING, INC.
3556
In Commercial Distribution

  • G40935560 ()
3556

  • First aid kit, medicated
No Description
IMMUNODIAGNOSTIC SYSTEMS LIMITED
IS-ID6502
In Commercial Distribution

  • 05060169695962 ()


  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
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