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Integra® 17185C12

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

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10381780034711 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  • Withdrawn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
17185C12
Primary DI / UDI-DI
10381780034711
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
  • 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