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DCTclock 10004

by Linus Health United States GUDID

Product code PTY

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberB626100040 UDI-DIDate16 Feb 2018ListedStatusIn distribution

Coverage

1 jurisdiction

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  • Listed
  • Not covered

United States — GUDID listing Listed

Recalls: none on record (FDA, checked 23 Oct 2026)

Specification

GUDID · synced 23 Oct 2026

Trade Name
DCTclock
Generic Name
Drawing-test cognitive function analysis device
Model / Ref / Catalog
10004
Primary DI / UDI-DI
B626100040
FDA Product Code
PTY
GMDN Term
Drawing-test cognitive function analysis device
Device Class
Class II
Regulation Number
882.1470
Commercial Distribution
In Commercial Distribution

Other devices from Linus Health

See all devices from Linus Health →

Properties & raw data

Show properties, registry sources and raw records
  • Prescription Use
  • Premarket Exempt
  • Serial Number
  • Manufacturing Date
Other properties (10)
  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Lot / Batch Number: No
  • Expiration Date: No

Sources (1)

  • FDA UDI 37631517-43ef-4424-9dd9-1d60495d8775 35 fields · synced 23 Oct 2026