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: Neurosign Disposable Monopolar Probe 200mm x 1.5mm electrode; 1.9 wire with DIN42802 connector FDA UDI
Model / Reference: 315-0000 FDA UDI
Description: Neurosign Disposable Monopolar Probe 200mm x 1.5mm electrode; 1.9 wire with DIN42802 connector FDA UDI

Identifiers

Primary DI / UDI-DI: 08718375865286 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.

ALARA Neuro Access Needle Kit — SURGENTEC LLC · Class II
Nerve Stimulator Probe — Koros USA, Inc. · Class II
Dragonfly® — NEUROVISION MEDICAL PRODUCTS, INC. · Class II
Cobra® — NEUROVISION MEDICAL PRODUCTS, INC. · Class II
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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Technomed Engineering B.V.

Sources (1)

FDA UDI baa9efe3-2b0e-437f-bc89-44c883744469 34 fields · synced May 30, 2026