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Reusable Safety Snap Leads 40" (3) for Duet/Aria/Solo M013933S

by Intelligent Hearing Systems Corp.

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 Number00817020021119 UDI-DI Date10 Jun 2026ListedStatusListed 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  • Withdrawn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
Reusable Safety Snap Leads 40" (3) for Duet/Aria/Solo
Generic Name
Analytical scalp lead
Model / Reference
M013933S
Primary DI / UDI-DI
00817020021119
FDA Product Code
IKD
GMDN Term
Analytical scalp lead
Device Class
Class II
Regulation Number
890.1175
GUDID distribution status
In Commercial Distribution

Other devices from Intelligent Hearing Systems Corp.

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Properties

  • Prescription Use
  • Premarket Exempt
  • Lot / Batch 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
  • Serial Number: No
  • Expiration Date: No