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Na DME1004

by Medtronic Xomed, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

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 Number20613994802365 UDI-DI Date30 Apr 2016ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Generic Name
Subdermal needle electrode
Model / Reference
DME1004
Primary DI / UDI-DI
20613994802365
510(k) Number
FDA Product Code
GXY
GMDN Term
Subdermal needle electrode
Device Class
Class II
Regulation Number
882.1320
GUDID distribution status
In Commercial Distribution
Size
Width — 35.0 Millimeter
Length — 50.0 Millimeter
Length — 2.0 Meter

Related devices

Category: Subdermal needle electrode

Cleared under the same submission (K062198)

Show all (12)

Other devices from Medtronic Xomed, Inc.

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Properties

  • Single Use
  • Prescription Use
  • Lot / Batch Number

Other properties (11)

  • Sterile: 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