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Na DSE0005

by Medtronic Xomed, Inc.

Listed FDA GUDID listing, no authorization on record

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

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number20613994910800 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  • Withdrawn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

Specification

GUDID

Generic Name
Transcutaneous electrical stimulation lead
Model / Reference
DSE0005
Primary DI / UDI-DI
20613994910800
510(k) Number
FDA Product Code
ITX, GWQ, GWE, GWF, IYN, GWJ
GMDN Term
Transcutaneous electrical stimulation lead
Device Class
Class II
Regulation Number
892.1570, 882.1400, 882.1890, 882.1870, 892.1550, 882.1900
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.

See all devices from Medtronic Xomed, Inc. →

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