Schiller ECG EL-LT C 1.3/0.78 x4 IEC

FDA UDI

Class II (US FDA UDI)

by Schiller Corp.

Identity

Trade Name: Schiller ECG EL-LT C 1.3/0.78 x4 IEC FDA UDI
Generic Name: Electrocardiographic lead set, reusable FDA UDI
Device Name: Detachable single wires clip type, Balanced Set 4 pcs (C3r, C4r, C8, C9) for patient cable 2.400140, 2.400139 FDA UDI
Model / Reference: 2.410099 FDA UDI
Description: Detachable single wires clip type, Balanced Set 4 pcs (C3r, C4r, C8, C9) for patient cable 2.400140, 2.400139 FDA UDI

Identifiers

Primary DI / UDI-DI: 07613365003802 FDA UDI
510(k) Number: K183425 FDA UDI
FDA Product Code: DSA FDA UDI
GMDN Term: Electrocardiographic lead set, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.2900 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Electrocardiographic lead set, reusable

Schiller ECG EL-LT C 1.3/0.78 x4 IEC by Schiller Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Electrocardiographic lead set, reusable.

Unimed — Unimed Medical Supplies, Inc. · Class II
Unimed — Unimed Medical Supplies, Inc. · Class II
Reusable EKG / ECG Leadwire — METKO MEDİKAL VE TIBBİ CİHAZLAR DIŞ TİCARET SANAYİ ANONİM ŞİRKETİ · Class I
Unimed — Unimed Medical Supplies, Inc. · Class II
Unimed — Unimed Medical Supplies, Inc. · Class II
ECG D-SUB2 C 3.5/3.1 x14 AHA — Schiller AG · Class I
Unimed — Unimed Medical Supplies, Inc. · Class II
Unimed — Unimed Medical Supplies, Inc. · Class II

Cleared under the same submission

K183425 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: Schiller Corp.

Sources (1)

FDA UDI a4b1e4ab-92f5-4789-bd71-3604343b7944 35 fields · synced May 31, 2026