Cadwell

FDA UDI

Class II (US FDA UDI)

by Technomed Engineering B.V.

Identity

Trade Name: Cadwell FDA UDI
Generic Name: Electromyographic needle electrode, single-use FDA UDI
Device Name: Disposable Hypodermic Needle Electrode, violet hub FDA UDI
Model / Reference: 202455-000 FDA UDI
Description: Disposable Hypodermic Needle Electrode, violet hub FDA UDI

Identifiers

Primary DI / UDI-DI: 08720791377441 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

MRI Safety

MR Unsafe FDA UDI

Dimensions & Sizes

Size: Length — 75 Millimeter FDA UDI
Outer Diameter — 0.70 Millimeter FDA UDI
Needle Gauge — 22 Gauge FDA UDI

Category: Electromyographic needle electrode, single-use

Cadwell by Technomed Engineering B.V. — 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: Technomed Engineering B.V.

Sources (1)

FDA UDI 68ed0456-1999-49f4-b986-ddbecb45b413 35 fields · synced May 31, 2026