Neuroline InojectNeurology Needle Electrodes

FDA UDI

Class II (US FDA UDI)

by Ambu A/S

Identity

Trade Name: Neuroline InojectNeurology Needle Electrodes FDA UDI
Generic Name: Electromyographic needle electrode, single-use FDA UDI
Device Name: Neurology needle electrodes FDA UDI
Model / Reference: 74438-45/10 FDA UDI
Description: Neurology needle electrodes FDA UDI

Identifiers

Catalog Number: 74438-45/10 FDA UDI
Primary DI / UDI-DI: 05707480023837 FDA UDI
FDA Product Code: IKT FDA UDI
GMDN Term: Electromyographic needle electrode, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 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

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

FDA UDI

Dimensions & Sizes

Size: Lumen/Inner Diameter — 0.45 Millimeter FDA UDI
Length — 38 Millimeter FDA UDI

Category: Electromyographic needle electrode, single-use

Neuroline InojectNeurology Needle Electrodes by Ambu A/S — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Ambu A/S

Sources (1)

FDA UDI 0ea0cb22-db75-4fbf-a0f3-6a42d6a895e0 37 fields · synced May 30, 2026