NeuroTrace

FDA UDI

Class II (US FDA UDI)

by Neo Medical Inc.

Identity

Trade Name: NeuroTrace FDA UDI
Generic Name: Nerve-locating system FDA UDI
Device Name: Neuro-Trace II Lead Cable FDA UDI
Model / Reference: 501-12 FDA UDI
Description: Neuro-Trace II Lead Cable FDA UDI

Identifiers

Catalog Number: 501-12 FDA UDI
Primary DI / UDI-DI: B339501120 FDA UDI
510(k) Number: K831715 FDA UDI
FDA Product Code: ETN FDA UDI
GMDN Term: Nerve-locating system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 874.1820 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

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

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Nerve-locating system

NeuroTrace by Neo Medical Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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NIM-ECLIPSE® — MEDTRONIC XOMED, INC. · Class II
NIM-Eclipse® — MEDTRONIC XOMED, INC. · Class II
SENTIO — Medos International Sàrl · Class II
Halyard — Avanos Medical, Inc. · Class II

Cleared under the same submission

K831715 also covers:

NeuroTrace — Neo Medical Inc.

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: Neo Medical Inc.

Sources (1)

FDA UDI 30131293-1898-404b-b3e5-f297e6e3f5bb 36 fields · synced May 30, 2026