Spineology

FDA UDI

Class II (US FDA UDI)

by Technomed Engineering B.V.

Identity

Trade Name: Spineology FDA UDI
Generic Name: Nerve-locating system probe, single-use FDA UDI
Device Name: Spineology Disposable Monopolar Neuro Probe, Detachable 500mmx2.4mm electrode, 1pc FDA UDI
Model / Reference: 312-0060 FDA UDI
Description: Spineology Disposable Monopolar Neuro Probe, Detachable 500mmx2.4mm electrode, 1pc FDA UDI

Identifiers

Primary DI / UDI-DI: 08718375869703 FDA UDI
FDA Product Code: GXZ 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
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

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

Category: Nerve-locating system probe, single-use

Spineology 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 5adb34ad-8d35-4def-853a-4e7dd0d27fa9 34 fields · synced May 30, 2026