Skip to content

Integra® ECCFS32

by Integra Neurosciences Implant (France)

Listed FDA GUDID listing, not in commercial distribution

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 23 Oct 2026. What this means

Overview

Integra is a high-quality, non-invasive EEG device designed for clinical use in the assessment and monitoring of brain activity. The Integra Cortical and Depth electrodes provide a reusable solution for connecting to an EEG monitor through 4 Cam Lock cylindrical Connectors, allowing for easy disconnection if desired.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10381780037040 UDI-DI Date12 Aug 2016ListedStatusListed GUDID: not 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  • Withdrawn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
Integra®
Generic Name
Analytical scalp lead
Model / Reference
ECCFS32
Primary DI / UDI-DI
10381780037040
FDA Product Code
IKD
GMDN Term
Analytical scalp lead
Device Class
Class II
Regulation Number
890.1175
GUDID distribution status
Not in Commercial Distribution
Sterilization Method
Ethylene Oxide
MRI Safety
MR Unsafe

Properties

  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (9)

  • 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