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Na 8253085

by Medtronic Xomed, Inc. 2 variants

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

3 closed

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 Number00613994499608 UDI-DI Date2 May 2016ListedStatusListed GUDID: not in commercial distribution

Recalls

3 recalls · FDA

  • 3 recalls, same reason

    • Terminated Z-2343-2012 FDA Class II initiated 27 Sep 2010
    • Terminated Z-2342-2012 FDA Class II initiated 27 Sep 2010
    • Terminated Z-2344-2012 FDA Class II initiated 27 Sep 2010

    In January 2010, Medtronic issued a recall of Medtronic NIM 3.0 Patient Interfaces after Medtronic identified a trend of open channel conditions (signal loss from the electrode). When the NIM 3.0 detects the signal loss from the electrode (i.e. open channel), it fails the electrode check and provides an audible and visual warning to the user which could also create a delay in the surgical procedu

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Generic Name
Nerve-locating system
Model / Reference
8253085
Primary DI / UDI-DI
00613994499608
510(k) Number
FDA Product Code
GWF, ETN
GMDN Term
Nerve-locating system
Device Class
Class II
Regulation Number
882.1870, 874.1820
GUDID distribution status
Not in Commercial Distribution

Related devices

Cleared under the same submission (K083124)

Show all (12)

Other devices from Medtronic Xomed, Inc.

See all devices from Medtronic Xomed, Inc. →

Properties

  • Prescription Use
  • Lot / Batch Number

Other properties (12)

  • 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
  • Manufacturing Date: No