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Na 8225751

by Medtronic Xomed, Inc. 2 variants

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

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 Number00613994896704 UDI-DIDate2 May 2016ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

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  • Withdrawn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
8225751
Primary DI / UDI-DI
00613994896704
510(k) Number
FDA Product Code
IKN, GWF, ETN
GMDN Term
Nerve-locating system
Device Class
Class II
Regulation Number
890.1375, 882.1870, 874.1820
GUDID distribution status
In Commercial Distribution
Size
Length — 2.3 Millimeter

Related devices

Category: Nerve-locating system

Cleared under the same submission (K031510)

Show all (12)

Other devices from Medtronic Xomed, Inc.

See all devices from Medtronic Xomed, Inc. →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number

Other properties (10)

  • 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