Mrqd42415

FDA UDI

Class II (US FDA UDI)

by Rhythmlink International, LLC

Identity

Trade Name: MRQD42415 FDA UDI
Generic Name: Analytical scalp electrode, single-use FDA UDI
Device Name: 4 Array MR/CT Conditional Quick Connect, 180mm Deep Cup, 1.5m in (1) Bundle and (1) MR Sticky Pad, 1.5m – 24 Pack FDA UDI
Model / Reference: MRQD42415 FDA UDI
Description: 4 Array MR/CT Conditional Quick Connect, 180mm Deep Cup, 1.5m in (1) Bundle and (1) MR Sticky Pad, 1.5m – 24 Pack FDA UDI

Identifiers

Primary DI / UDI-DI: 00816312026849 FDA UDI
FDA Product Code: GXY FDA UDI
GMDN Term: Analytical scalp electrode, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.1320 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Analytical scalp electrode, single-use

Mrqd42415 by Rhythmlink International, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Analytical scalp electrode, single-use.

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BRAINSTREAM — Conmed Corporation · Class II
Spes Medica Disc Electrode — SPES MEDICA SPA · Class II
MR Conditional Disposable EEG Cup Electrode — SPES MEDICA SPA · Class II
GoldSelect™ — Advantage Medical Electronics, LLC · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Rhythmlink International, LLC

Sources (1)

FDA UDI 5069906a-a0b1-4e7a-a5c7-fad8fbf9f346 35 fields · synced Jun 9, 2026