← Back to catalogue

Cap Straps - Small

FDA UDI

Class II (US FDA UDI)

by Electro-Cap International Inc

Identity

Trade Name
CAP STRAPS - SMALL FDA UDI
Generic Name
Analytical scalp lead FDA UDI
Model / Reference
E13-SM FDA UDI

Identifiers

Catalog Number
E13-SM FDA UDI
Primary DI / UDI-DI
00811478011968 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

No

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

Cap Straps - Small 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Electro-Cap International Inc

Sources (1)

  • FDA UDI 03996051-4e67-42df-b6c2-ade561f25d95 35 fields · synced May 30, 2026