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Cadwell Easy2 System 2

FDA UDI

Class II (US FDA UDI)

by Electro-Cap International Inc

Identity

Trade Name
CADWELL EASY2 SYSTEM 2 FDA UDI
Generic Name
Analytical scalp lead FDA UDI
Model / Reference
EASY2-SYS2 FDA UDI

Identifiers

Catalog Number
EASY2-SYS2 FDA UDI
Primary DI / UDI-DI
00811478010107 FDA UDI
510(k) Number
K112319 FDA UDI
FDA Product Code
GXY FDA UDI
GMDN Term
Analytical scalp lead FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.1320 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Analytical scalp lead

Cadwell Easy2 System 2 by Electro-Cap International Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Analytical scalp lead.

Cleared under the same submission

K112319 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Electro-Cap International Inc

Sources (1)

  • FDA UDI a0a02bbf-e197-44e2-aaf9-c820e62f3dfd 35 fields · synced May 30, 2026