Corkscrew Electrode

Basic Information

• Brand Name: Corkscrew Electrode
• Primary DI: 00852373007199
• Version / Model: 003-400001-5
• Catalog Number: 003-400001-5
• Company Name: SGM d.o.o.
• Labeler DUNS: 499490357
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2018-03-23
• Public Version: 4
• Public Version Date: 2018-08-09
• Public Version Status: Update
• Public Device Record Key: aa7533a0-98a3-474f-9f56-9f2137a6993d

Device Description

Corkscrew electrode CS-F (2m) 003-400001-5. Five twisted electrodes in double package to preserve sterility of the product. Use for one medical operation.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GXZ	Electrode, Needle	Neurology	882.1350	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47714	Subdermal needle electrode	A sterile, multi-purpose electrical conductor inserted beneath the dermal layer of a patient's skin to record/monitor electrical activity (biopotentials) for physiological measurements [typically electroencephalography (EEG), electromyography (EMG), and evoked-potential) and often to provide electrical stimulation. It typically consists of thin shaft of stainless steel connected to a lead wire that terminates with a safety connector for attachment to recording/monitoring and stimulation systems. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00852373007212	GS1	carton box	350	In Commercial Distribution
Primary	00852373007199	GS1
Package	00852373007205	GS1	carton box	300	In Commercial Distribution
Unit of Use	00852373007045	GS1
Package	00852373007267	GS1	Carton box	2	Not in Commercial Distribution	2018-08-08
Package	00852373007274	GS1	Carton box	100	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K934779	000

Device Sizes

Type	Value	Unit	Text
Length	2	Meter