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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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No Description
Qr8 Health Inc
CHR-COG-W10
Not in Commercial Distribution

  • 00860007318726 ()


  • Cognitive assessment software
No Description
Qr8 Health Inc
SNP-COG-20
Not in Commercial Distribution

  • 00860007318719 ()


  • Cognitive assessment software
No Description
Qr8 Health Inc
SNP-COG-10
Not in Commercial Distribution

  • 00860007318702 ()


  • Cognitive assessment software
No Description
Hangzhou Universal Electronic Co.,Ltd.
9500
In Commercial Distribution

  • 00860007291128 ()


  • Intermittent electronic patient thermometer
Canvas Dx is a prescription diagnostic aid to healthcare professionals (HCP) considering the diagnosis of Autism Spectrum Disorder (ASD) in patients 18 months through 72 months of age at risk for developmental delay. The patient’s caregiver uses a smartphone application (“App”) to fill out a caregiver questionnaire and to make video recordings of behavior at home, and then the physician fills out a medical questionnaire online. The results are made available to the physician.
Cognoa, Inc.
1.3.0
In Commercial Distribution

  • 00860007260605 ()


  • Neurodevelopmental disorder interpretive software
The NeuraMedica Instrument Tray is a separately-supplied reusable surgical tray that holds the instrument that aids in the installation of the NeuraMedica Durafuse Dural Clips.
Neuramedica Inc.
TR-200
In Commercial Distribution

  • 00860007130434 ()


  • Instrument tray, reusable
The NeuraMedica Instrument Tray is a separately-supplied reusable surgical tray that holds the instrument that aids in the installation of the NeuraMedica Durafuse Dural Clips.
Neuramedica Inc.
TR-100
In Commercial Distribution

  • 00860007130427 ()


  • Instrument tray, reusable
NeuraMedica Dural Clips are bioabsorbable surgical clips designed to aid in closure of the dura mater in neurosurgical and orthopedic spine procedures. NeuraMedica Dural Clips are 3mm wide by 4.6mm long. They are applied using a reusable stainless steel applier. The NeuraMedica Applier is a separately-supplied reusable instrument.
Neuramedica Inc.
DC-501
In Commercial Distribution

  • 00860007130403 ()


  • Ligation clip, synthetic polymer, bioabsorbable
Coolject 1-3 cc Syringe Holder Nozzle Accessory, One per Box
Vapocoolshot, Inc
VM01000-00
In Commercial Distribution

  • 00860006961534 ()


  • Biopsy syringe holder, reusable
Medical Ultraviolet Air Purifier
ACTIVEPURE MEDICAL LLC
F170A
In Commercial Distribution

  • 00860006810108 ()


  • High-efficiency filter air cleaner, mobile
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