Rhythmlink®

FDA UDI

Class II (US FDA UDI)

by Rhythmlink International, LLC

Identity

Trade Name: Rhythmlink® FDA UDI
Generic Name: Subdermal needle electrode FDA UDI
Device Name: Disposable Subdermal Needle Electrodes and Sticky Pad Surface Electrode FDA UDI
Model / Reference: RLSP532 FDA UDI
Description: Disposable Subdermal Needle Electrodes and Sticky Pad Surface Electrode FDA UDI

Identifiers

Primary DI / UDI-DI: 00816312024487 FDA UDI
FDA Product Code: GXZ FDA UDI
GXY FDA UDI
GMDN Term: Subdermal needle electrode FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.1350 FDA UDI
882.1320 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

Yes

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

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Analytical non-scalp cutaneous electrode Subdermal needle electrode

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

Similar devices

Also classified as Subdermal needle electrode.

Neuroline Twisted Pair SubdermalNeurology Needle Electrodes — Ambu A/S · Class II
Horizon™ — Advantage Medical Electronics, LLC · Class II
Neuroradium — Technomed Engineering B.V. · Class II
Sphenoidal Electrode Set — Ad-Tech Medical Instrument Corp. · Class II
Spinal Electrode Kit — Ad-Tech Medical Instrument Corp. · Class II
Horizon™ — Advantage Medical Electronics, LLC · Class II
Neuroline SubdermalNeurology Needle Electrodes — Ambu A/S · Class II
Horizon™ — 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Rhythmlink International, LLC

Sources (1)

FDA UDI 90c801ee-b415-4228-b1b0-753cbffd2626 35 fields · synced Jun 9, 2026