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Na 8227136

by Medtronic Xomed, Inc. GUDID

Listed FDA GUDID listing, not in commercial distribution

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number20643169938582 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  • Withdrawn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

Recalls

0 recalls · FDA

No FDA recalls on record, checked 23 Oct 2026.

Specification

GUDID

Generic Name
Subdermal needle electrode
Model / Reference
8227136
Primary DI / UDI-DI
20643169938582
510(k) Number
FDA Product Code
GXZ
GMDN Term
Subdermal needle electrode
Device Class
Class II
Regulation Number
882.1350
GUDID distribution status
Not in Commercial Distribution
Size
Length — 1.5 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