DCTclock 10039

GUDID B626100391

Drawing-test cognitive function analysis device

Primary Device ID	B626100391
NIH Device Record Key	9bdfafa2-6bbd-4ded-9d90-d51c3764df0b
Commercial Distribution Status	In Commercial Distribution
Brand Name	DCTclock
Version Model Number	10039
Catalog Number	10039
Company DUNS	047303734
Company Name	DIGITAL COGNITION TECHNOLOGIES, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	true
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
HIBCC	B626100390 [Primary]
HIBCC	B626100391 [Package] Contains: B626100390 Package: shrink wrap [10 Units] In Commercial Distribution

PTY	Computerized Cognitive Assessment Aid, Exempt

Steralize Prior To Use	false
Device Is Sterile	false

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Mark Image Registration \| Serial	Company Trademark Application Date
DCTCLOCK 97316012 not registered Live/Pending	Linus Health, Inc. 2022-03-16