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Polysmith 12.3

by Neurotronics, LLC

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00817111021332 UDI-DI Date23 Sep 2025ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Polysmith
Generic Name
Sleep disorder interpretive software, professional-only
Model / Reference
12.3
Primary DI / UDI-DI
00817111021332
FDA Product Code
OLZ, OLV, DQA, MNR, GWL, MLO
GMDN Term
Sleep disorder interpretive software, professional-only
Device Class
Class II
Regulation Number
882.1400, 870.2700, 868.2375, 882.1835, 870.2800
GUDID distribution status
In Commercial Distribution

Other devices from Neurotronics, LLC

See all devices from Neurotronics, LLC →

Properties

  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No