Cadwell

FDA UDI

Class II (US FDA UDI)

by Technomed Engineering B.V.

Identity

Trade Name: Cadwell FDA UDI
Generic Name: Subdermal needle electrode FDA UDI
Device Name: Disposable Subdermal Needle Electrode, parallel; 18x0.38mm 2.5m parallel wire 12pairs FDA UDI
Model / Reference: 302915-000-GP2 FDA UDI
Description: Disposable Subdermal Needle Electrode, parallel; 18x0.38mm 2.5m parallel wire 12pairs FDA UDI

Identifiers

Primary DI / UDI-DI: 08720791377021 FDA UDI
FDA Product Code: GXZ FDA UDI
IKT FDA UDI
GMDN Term: Subdermal needle electrode FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.1350 FDA UDI
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 — 18 Millimeter FDA UDI
Outer Diameter — 0.38 Millimeter FDA UDI

Category: Subdermal needle electrode

Cadwell by Technomed Engineering B.V. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Horizon™ — Advantage Medical Electronics, LLC · Class II
Neuroline SubdermalNeurology Needle Electrodes — Ambu A/S · Class II
Rhythmlink® — Rhythmlink International, LLC · 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 8a24318b-72ef-4cb1-aff5-8bf092baf027 35 fields · synced May 30, 2026