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Rhythmlink®

FDA UDI

Class II (US FDA UDI)

by Rhythmlink International, LLC

Identity

Trade Name
Rhythmlink® FDA UDI
Generic Name
Transcutaneous electrical stimulation electrode, single-use FDA UDI
Device Name
Oracle Neuromonitoring Kit FDA UDI
Model / Reference
RLSP210 FDA UDI
Description
Oracle Neuromonitoring Kit FDA UDI

Identifiers

Catalog Number
03.809.002S FDA UDI
Primary DI / UDI-DI
00816312022223 FDA UDI
FDA Product Code
GXY FDA UDI
GXZ FDA UDI
ETN FDA UDI
GMDN Term
Transcutaneous electrical stimulation electrode, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.1320 FDA UDI
882.1350 FDA UDI
874.1820 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Transcutaneous electrical stimulation electrode, single-useSubdermal needle electrodeDiagnostic peripheral nerve electrical stimulation system

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

Similar devices

Also classified as Diagnostic peripheral nerve electrical stimulation system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Rhythmlink International, LLC

Sources (1)

  • FDA UDI d35ea798-2f75-4e8d-9533-dbc2dd442e6f 35 fields · synced Jun 9, 2026