Skip to content

Na 8227418

by Medtronic Xomed, Inc. 3 variants

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

A comprehensive medical device directory listing for the Electromyographic Needle Electrode, a sterile electrical conducting device designed to detect bioelectrical signal activity.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number20643169938728 UDI-DIDate26 Mar 2018ListedStatusListed 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  • Withdrawn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

Generic Name
Electromyographic needle electrode, single-use
Model / Reference
8227418
Primary DI / UDI-DI
20643169938728
510(k) Number
FDA Product Code
GXZ
GMDN Term
Electromyographic needle electrode, single-use
Device Class
Class II
Regulation Number
882.1350
GUDID distribution status
Not in Commercial Distribution
Size
Length — 18.0 Millimeter

Related devices

Cleared under the same submission (K850107)

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