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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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Welch Allyn RETeval-DR Electroretinograph including Disposable Sensor Strips (2 Packs of 50 ea), Charging Dock, and USB Cable; Lithium-Ion Battery (#RETeval-ACC-02); 100-240 V, 50-60 Hz, IEC Plug Types A, G, E/F, and I; Multiple Languages
WELCH ALLYN, INC.
901101
In Commercial Distribution

  • 00732094214741 ()
RETEVAL-001

  • Ophthalmic fundus camera
RETINAVUE700 IMAGER SET US PLUG
WELCH ALLYN, INC.
901124
Not in Commercial Distribution

  • 00732094258851 ()
RV700-B

  • Ophthalmic fundus camera
RETINAVUE100 IMAGER PRO SET US PLUG
WELCH ALLYN, INC.
901103
In Commercial Distribution

  • 00732094252835 ()
RV100PRO-B

  • Ophthalmic fundus camera
The Resolve Fundus Camera is an automatic eye-fundus camera intended for taking digital images of a human retina with or without the use of a mydriatic agent. It is intended for use as an aid to clinicians in the evaluation and diagnosis of ocular health.
Optain Health, Inc.
Resolve Fundus Camera
In Commercial Distribution

  • 00860014304507 ()


  • Ophthalmic fundus camera
No Description
RETIVUE, LLC
WFP-B-G1.5-0A
In Commercial Distribution

  • 00860011978305 ()


  • Ophthalmic fundus camera
No Description
Spark Neuro Inc.
SP010000
In Commercial Distribution

  • 00860011882022 ()


  • Cognitive assessment software
No Description
Qr8 Health Inc
SNP-COG-24
In Commercial Distribution

  • 00860011850922 ()


  • Cognitive assessment software
No Description
Qr8 Health Inc
MSPT-W310
In Commercial Distribution

  • 00860011850915 ()


  • Cognitive assessment software
No Description
Qr8 Health Inc
MSPT-311
In Commercial Distribution

  • 00860011850908 ()


  • Cognitive assessment software
BrainCheck Assess is a digital cognitive assessment platform.
Braincheck, Inc.
2
In Commercial Distribution

  • 00860011154501 ()


  • Cognitive assessment software
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