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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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THE EMERGENCY ELASTIC WRAP - 4"
EINSTEIN WORKS, LLC
1
In Commercial Distribution

  • 00860017001298 ()


  • Pressure bandage, non-latex, single-use
No Description
Color Diagnostics, LLC
1.0
In Commercial Distribution

  • 00860014139307 ()


  • Specimen stabilization reagent IVD
  • Oral/respiratory tract specimen container IVD, additive/medium
No Description
LARONIX PTY LTD
1.0
In Commercial Distribution

  • 00860013939014 ()


  • Transcervical artificial larynx
Tendon Seam™ Magazine - 4 Anchor
Integrity Orthopaedics, Inc
901004
In Commercial Distribution

  • 00860013905989 ()
901004

  • Tendon/ligament bone anchor, non-bioabsorbable
Delivery Instrument, included with Tendon Seam™ Instrument Kit - 4 Anchor
Integrity Orthopaedics, Inc
902001
In Commercial Distribution

  • 00860013905965 ()
902001

  • Orthopaedic inorganic implant inserter/extractor, single-use
Tendon Seam™ Instrument Kit - 8 Anchor
Integrity Orthopaedics, Inc
901003
In Commercial Distribution

  • 00860013905934 ()
901003

  • Orthopaedic inorganic implant inserter/extractor, single-use
  • Tendon/ligament bone anchor, non-bioabsorbable
Sterile Empty EVA Pillow Bag, 4000 mL, 3 Ports, With One LF Port
INTERNATIONAL FILTER PRODUCTS, INC.
IFP-17G-0400
In Commercial Distribution

  • 00860013851262 ()
  • 10860013851269 ()
IFP-17G-0400

  • Intravenous administration bag/bottle
Sterile Empty EVA Pillow Bag, 250 mL, 3 Ports, With One LF Port
INTERNATIONAL FILTER PRODUCTS, INC.
IFP-17G-0025
In Commercial Distribution

  • 00860013851217 ()
  • 10860013851214 ()
IFP-17G-0025

  • Intravenous administration bag/bottle
NxGen Peak Flow Meter is intended to measure Peak Expiratory Flow (PEF) and Forced Expiratory Volume in one second (FEV1) in home healthcare environment. The device is designed for children greater than five years of age, adolescent and adult subjects.
SAFEY MEDICAL DEVICES PRIVATE LIMITED
165253
In Commercial Distribution

  • 00860013746407 ()

  • Weight: 300 Gram


  • Expiratory peak flow meter, digital
The NeuroSync EYE-SYNC device is a portable, fully enclosed eye tracking environment with two primary components: 1. Eye Tracker (head-mounted device) with eye tracking sensor and display 2. Android Tablet The eye tracker is a Pico Neo 3 Pro Eye with embedded sensors provided by Tobii Tech. It is mounted to the subject's face and held in place using a strap. The eye tracking sensor includes two cameras (one for each eye) to capture eye movement data. Eye gaze tracking is performed using a proprietary implementation of the pupil-corneal reaction method. The integrated display within the headset provides a binocular visual field and operates as part of the standalone VR system, running on Qualcomm Snapdragon XR2 hardware. The headset processes eye-tracking data internally and supports USB-C connectivity. The display receives eye tracking sensor information for post-processing, manages sensor calibration, provides binocular visual display to the subject, and interfaces with the Android tablet over Bluetooth. Eye gaze tracking and visual display is combined to provide several assessment paradigms to characterize subject eye tracking performance.
NEUROSYNC INC.
X03
In Commercial Distribution

  • 00860013612900 ()


  • Vision physiology/eye movement analysis system
  • Eye-tracking neurological/brain injury assessment device
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