Dantec

FDA UDI

Class II (US FDA UDI)

by Natus Manufacturing Limited

Identity

Trade Name: Dantec FDA UDI
Generic Name: Electromyographic needle electrode, single-use FDA UDI
Device Name: DantecTM DCN FDA UDI
Model / Reference: 9013S0022 FDA UDI
Description: DantecTM DCN FDA UDI

Identifiers

Primary DI / UDI-DI: 05704736002868 FDA UDI
510(k) Number: K112034 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

Yes

FDA UDI

Category: Electromyographic needle electrode, single-use

Dantec by Natus Manufacturing Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Electromyographic needle electrode, single-use.

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Neuroline InojectNeurology Needle Electrodes — Ambu A/S · Class II
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BIONEN — BIONEN SAS DI BARBARA NENCIONI & C. · Class II

Cleared under the same submission

K112034 also covers:

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: Natus Manufacturing Limited

Sources (1)

FDA UDI 8a97d618-7aa7-4e10-97df-f8bf06d71e23 34 fields · synced Jun 8, 2026