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Na DSE0003

by Medtronic Xomed, Inc. GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number20613994910787 UDI-DIDate30 Apr 2016ListedStatusListed GUDID: 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  • Withdrawn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
Transcutaneous electrical stimulation lead
Model / Reference
DSE0003
Primary DI / UDI-DI
20613994910787
510(k) Number
FDA Product Code
GWE, IYN, ITX, GWJ, GWQ, GWF
GMDN Term
Transcutaneous electrical stimulation lead
Device Class
Class II
Regulation Number
882.1890, 892.1550, 892.1570, 882.1900, 882.1400, 882.1870
GUDID distribution status
In Commercial Distribution
Size
Length — 1.2 Meter

Related devices

Category: Transcutaneous electrical stimulation lead

Cleared under the same submission (K061639)

Show all (12)

Other devices from Medtronic Xomed, Inc.

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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