NeuroTherm™

FDA UDI

Class II (US FDA UDI)

by Neuro Therm, Inc.

Identity

Trade Name: NeuroTherm™ FDA UDI
Generic Name: Electrosurgical return electrode, single-use FDA UDI
Device Name: Grounding Pad FDA UDI
Model / Reference: RF-DGP-L FDA UDI
Description: Grounding Pad FDA UDI

Identifiers

Catalog Number: RF-DGP-L FDA UDI
Primary DI / UDI-DI: 05415067023612 FDA UDI
FDA Product Code: GEI FDA UDI
GMDN Term: Electrosurgical return electrode, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.4400 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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Electrosurgical return electrode, single-use

NeuroTherm™ by Neuro Therm, Inc. — 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: Neuro Therm, Inc.

Sources (1)

FDA UDI f4268b73-7bc2-4386-88d3-3f12e4b470ed 35 fields · synced May 30, 2026