Horizon™

FDA UDI

Class II (US FDA UDI)

by Advantage Medical Electronics, LLC

Identity

Trade Name: Horizon™ FDA UDI
Generic Name: Subdermal needle electrode FDA UDI
Device Name: DISPOSABLE HORIZON SUBDERMAL NEEDLE ELECTRODES: 27 GA., 13 MM NEEDLE, 2.5 M RIBBON LEADWIRE (6-LEAD), COLOR GROUP R1 10/Box FDA UDI
Model / Reference: NS-S86025-R1-10 FDA UDI
Description: DISPOSABLE HORIZON SUBDERMAL NEEDLE ELECTRODES: 27 GA., 13 MM NEEDLE, 2.5 M RIBBON LEADWIRE (6-LEAD), COLOR GROUP R1 10/Box FDA UDI

Identifiers

Primary DI / UDI-DI: 00849593008679 FDA UDI
FDA Product Code: GXZ FDA UDI
GMDN Term: Subdermal needle electrode FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.1350 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Subdermal needle electrode

Horizon™ by Advantage Medical Electronics, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Spinal Electrode Kit — Ad-Tech Medical Instrument Corp. · Class II
Neuroline SubdermalNeurology Needle Electrodes — Ambu A/S · Class II
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Rhythmlink® — Rhythmlink International, 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: Advantage Medical Electronics, LLC

Sources (1)

FDA UDI d729802d-ac86-484c-b3e7-6744c2f33ad5 34 fields · synced May 30, 2026