Corkscrew Electrode

FDA UDI

Class II (US FDA UDI)

by SGM d.o.o.

Identity

Trade Name: Corkscrew Electrode FDA UDI
Generic Name: Subdermal needle electrode FDA UDI
Device Name: Corkscrew Electrode CS-F (1,0m) 003-400000-6. Six packed individual inside one package to preserve sterility of the product. Used as a set for one medical operation. FDA UDI
Model / Reference: 003-400000-6 FDA UDI
Description: Corkscrew Electrode CS-F (1,0m) 003-400000-6. Six packed individual inside one package to preserve sterility of the product. Used as a set for one medical operation. FDA UDI

Identifiers

Catalog Number: 003-400000-6 FDA UDI
Primary DI / UDI-DI: 00852373007021 FDA UDI
510(k) Number: K934779 FDA UDI
FDA Product Code: GXZ FDA UDI
GMDN Term: Subdermal needle electrode FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.1350 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

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

FDA UDI

Dimensions & Sizes

Size: Length — 1 Meter FDA UDI

Category: Subdermal needle electrode

Corkscrew Electrode CS-F (1.0m) is a sterile, multi-purpose electrical conductor used as a set for one medical operation in neurology. It consists of thin stainless steel shaft connected to a lead wire that terminates with a safety connector for attachment to recording/monitoring and stimulation systems. Designed for single-use implantations, this device features a six-packed individual design within one package to preserve sterility. Corkscrew Electrode CS-F (1.0m) is approved by FDA as Subdermal needle electrode.

Similar devices

Also classified as Subdermal needle electrode.

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Sphenoidal Electrode Set — Ad-Tech Medical Instrument Corp. · Class II
Spinal Electrode Kit — Ad-Tech Medical Instrument Corp. · Class II
Horizon™ — Advantage Medical Electronics, LLC · Class II
Neuroline SubdermalNeurology Needle Electrodes — Ambu A/S · Class II

Cleared under the same submission

K934779 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: SGM d.o.o.

Sources (1)

FDA UDI 60f89ec5-601c-4a77-8f53-aac7302358a1 37 fields · synced Jul 25, 2026