Medtronic Reusable Instruments

FDA UDI

Class I (US FDA UDI)

by Medtronic Sofamor Danek, Inc.

Identity

Trade Name: Medtronic Reusable Instruments FDA UDI
Generic Name: Nerve-locating system FDA UDI
Device Name: HANDLE X0906194 NIM PROBE BALL ATT FDA UDI
Model / Reference: X0906194 FDA UDI
Description: HANDLE X0906194 NIM PROBE BALL ATT FDA UDI

Identifiers

Primary DI / UDI-DI: 00613994375117 FDA UDI
FDA Product Code: LXH FDA UDI
GMDN Term: Nerve-locating system FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.4540 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Nerve-locating system

Medtronic Reusable Instruments by Medtronic Sofamor Danek, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Nerve-locating system.

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Halyard — Avanos Medical, Inc. · Class II
AVANOS — Avanos Medical, Inc. · Class II
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

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 I	Pending data

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Manufacturer

Manufacturer: Medtronic Sofamor Danek, Inc.

Sources (1)

FDA UDI 1d6d1b23-1ed3-4561-bc84-285ee808f0cb 34 fields · synced May 30, 2026