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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-W20
In Commercial Distribution

  • 00860007318788 ()


  • Cognitive assessment software
No Description
Qr8 Health Inc
SNP-COG-23
In Commercial Distribution

  • 00860007318771 ()


  • Cognitive assessment software
No Description
Qr8 Health Inc
CHR-COG-21
In Commercial Distribution

  • 00860007318764 ()


  • Cognitive assessment software
No Description
Qr8 Health Inc
SNP-COG-22
In Commercial Distribution

  • 00860007318757 ()


  • Cognitive assessment software
No Description
Qr8 Health Inc
SNP-GOG-21
Not in Commercial Distribution

  • 00860007318740 ()


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

  • 00860007318733 ()


  • Cognitive assessment software
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
No Description
Ellis Instruments Inc
#125-815
In Commercial Distribution

  • 00860007290664 ()


  • Surgical implant handling forceps
No Description
Ellis Instruments Inc
#125-080
In Commercial Distribution

  • 00860007290640 ()


  • Surgical implant handling forceps
No Description
Ellis Instruments Inc
#125-025
In Commercial Distribution

  • 00860007290626 ()


  • Surgical implant handling forceps
No Description
Ellis Instruments Inc
#125-024
In Commercial Distribution

  • 00860007290602 ()


  • Surgical implant handling forceps
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
Oscillating Saw Packaged Assembly
Insurgical, Inc.
320-0067-001
In Commercial Distribution

  • 00860007230035 ()
3010002

  • Bone/joint surgical power tool motorized handpiece/set, electric, single-use
Reciprocating Saw Packaged Assembly
Insurgical, Inc.
320-0071-001
In Commercial Distribution

  • 00860007230028 ()
3010003

  • Bone/joint surgical power tool motorized handpiece/set, electric, single-use
Drill-Reamer Packaged Assembly
Insurgical, Inc.
320-0064-001
In Commercial Distribution

  • 00860007230004 ()
3010001

  • Bone/joint surgical power tool motorized handpiece/set, electric, single-use
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
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