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Na 8227418

by Medtronic Xomed, Inc. GUDID 3 variants

Listed FDA GUDID listing, not in commercial distribution

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number20643169695041 UDI-DIDate15 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  • Withdrawn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

Recalls

0 recalls · FDA

No FDA recalls on record, checked 23 Oct 2026.

Specification

GUDID

Generic Name
Electromyographic needle electrode, single-use
Model / Reference
8227418
Primary DI / UDI-DI
20643169695041
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