Rochester S94025-A-24SC

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	Number10816843023642 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Withdrawn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: Rochester
Generic Name: Subdermal needle electrode
Model / Reference: S94025-A-24SC

Primary DI / UDI-DI: 10816843023642
FDA Product Code: GXZ
GMDN Term: Subdermal needle electrode

Device Class: Class II
Regulation Number: 882.1350
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
Lot / Batch Number
Expiration Date
Manufacturing Date

Other properties (8)

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