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UltraLast™ BMS045T15-10

by Rochester Electro-Medical, Inc.

Listed FDA GUDID listing, not in commercial distribution

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

Overview

UltraLast Electrode, Cutaneous, Reusable: A noninvasive electrical conductor designed for recording/monitoring changes in the electrical potential of various brain areas. This reusable device consists of a small cup/disk/star with conductive surface and may include an insulated connecting wire. It is typically available as a set of multiple electrodes but is not preconfigured. UltraLast Electrode is intended for use in neurological regulation, sleep, or evoked potential recording devices.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10816843020450 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: not in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
UltraLast™
Generic Name
Analytical scalp electrode, reusable
Model / Reference
BMS045T15-10
Primary DI / UDI-DI
10816843020450
FDA Product Code
GXY
GMDN Term
Analytical scalp electrode, reusable
Device Class
Class II
Regulation Number
882.1320
GUDID distribution status
Not in Commercial Distribution

Other devices from Rochester Electro-Medical, Inc.

Properties

  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No