UltraPoint™ 016397

by Rochester Electro-Medical, Inc. 2 variants

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

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number10816843022614 UDI-DI	Date24 Sep 2016Listed	StatusListed GUDID: not in commercial distribution

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name: UltraPoint™
Generic Name: Electromyographic needle electrode, single-use
Model / Reference: 016397

Primary DI / UDI-DI: 10816843022614
FDA Product Code: IKT
GMDN Term: Electromyographic needle electrode, single-use

Device Class: Class II
Regulation Number: 890.1385
GUDID distribution status: Not in Commercial Distribution

Other devices from Rochester Electro-Medical, Inc.

Disposable Pre-Gelled Surface Electrode

Class II
Ultrasharp Concentric Needles

Class II

Properties

Sterile
Single Use
Prescription Use
Premarket Exempt
Lot / Batch Number
Expiration Date

Other properties (8)

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