ENT NIM Electrode

FDA UDI

Class II (US FDA UDI)

by Medtronic Xomed, Inc.

Identity

Trade Name: ENT NIM Electrode FDA UDI
Generic Name: Nerve-locating system FDA UDI
Device Name: PROBE 8225276 BALL TIP 2.3MM ROHS FDA UDI
Model / Reference: 8225276 FDA UDI
Description: PROBE 8225276 BALL TIP 2.3MM ROHS FDA UDI

Identifiers

Primary DI / UDI-DI: 00763000891879 FDA UDI
510(k) Number: K992869 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

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

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Ethylene Oxide FDA UDI

Category: Nerve-locating system

ENT NIM Electrode by Medtronic Xomed, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Halyard — Avanos Medical, Inc. · Class II
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NIM-Eclipse — MEDTRONIC SOFAMOR DANEK, INC. · Class II
AVANOS — Avanos Medical, Inc. · Class II

Cleared under the same submission

K992869 also covers:

ENT NIM Electrode — MEDTRONIC XOMED, 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: Medtronic Xomed, Inc.

Sources (1)

FDA UDI 33721fa1-863d-4f39-83de-d33f32b55676 35 fields · synced May 31, 2026