NuFACE

FDA UDI

Class II (US FDA UDI)

by Nuface

Identity

Trade Name: NuFACE FDA UDI
Generic Name: Electrode conductive medium FDA UDI
Device Name: Leave-On Gel Primer 2oz. - FDA UDI
Model / Reference: 30410 FDA UDI
Description: Leave-On Gel Primer 2oz. - FDA UDI

Identifiers

Primary DI / UDI-DI: 00854278006864 FDA UDI
510(k) Number: K161654 FDA UDI
FDA Product Code: GYB FDA UDI
GMDN Term: Electrode conductive medium FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.1275 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

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

FDA UDI

Category: Electrode conductive medium

NuFACE by Nuface — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K161654 also covers:

NuFACE — Nuface
NuFACE — Nuface

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: Nuface

Sources (1)

FDA UDI e3466928-7803-4fa8-b2ae-565d15e9cd1f 34 fields · synced May 30, 2026