Ives EEG Solutions

FDA UDI

Class II (US FDA UDI)

by Ives EEG Solutions

Identity

Trade Name: Ives EEG Solutions FDA UDI
Generic Name: Analytical scalp lead FDA UDI
Device Name: Ives MR Conditional Electrode System Harness, 27 lead wire harness, MR Unsafe (disconnect from electrode set before CT or MR imaging) FDA UDI
Model / Reference: HAR-27 FDA UDI
Description: Ives MR Conditional Electrode System Harness, 27 lead wire harness, MR Unsafe (disconnect from electrode set before CT or MR imaging) FDA UDI

Identifiers

Primary DI / UDI-DI: 00850012681113 FDA UDI
FDA Product Code: IKD FDA UDI
GMDN Term: Analytical scalp lead FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 890.1175 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Analytical scalp lead

Ives EEG Solutions by Ives EEG Solutions — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Ives EEG Solutions

Sources (1)

FDA UDI a8cd252d-9744-49de-a329-9a57fc98debb 33 fields · synced May 31, 2026