Neurosign

FDA UDI

Class II (US FDA UDI)

by Technomed Engineering B.V.

Identity

Trade Name: Neurosign FDA UDI
Generic Name: Nerve-locating system probe, single-use FDA UDI
Device Name: NM-Kit 1 contains the following devices: 1x 3601-00-TE, UDI pouch: 08718375864982 2x 1699-00-TE, UDI pouch: 08718375865224 1x 1705-00-TE, UDI pouch: 08718375865231 FDA UDI
Model / Reference: NM-Kit 1 FDA UDI
Description: NM-Kit 1 contains the following devices: 1x 3601-00-TE, UDI pouch: 08718375864982 2x 1699-00-TE, UDI pouch: 08718375865224 1x 1705-00-TE, UDI pouch: 08718375865231 FDA UDI

Identifiers

Primary DI / UDI-DI: 08720791371463 FDA UDI
FDA Product Code: GXZ FDA UDI
IKT FDA UDI
GMDN Term: Nerve-locating system probe, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.1350 FDA UDI
890.1385 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

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

Yes

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

MRI Safety

MR Unsafe FDA UDI

Category: Subdermal needle electrode Nerve-locating system probe, single-use

Neurosign by Technomed Engineering B.V. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Nerve-locating system probe, single-use.

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SafeOp 3 — ALPHATEC SPINE, INC. · Class II
IOM Stimulator Probes — SPES MEDICA SPA · Class II
NIM-Spine® — MEDTRONIC SOFAMOR DANEK, INC. · Class II
Scorpion — NEUROVISION MEDICAL PRODUCTS, 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 II	Pending data

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Manufacturer

Manufacturer: Technomed Engineering B.V.

Sources (1)

FDA UDI 2943341e-e61b-4ec0-9df6-3019b6c9a813 34 fields · synced Jun 8, 2026