Corkscrew Electrode 003-400000-6

GUDID 00852373007021

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.

SGM d.o.o.

Subdermal needle electrode

• Primary Device ID: 00852373007021
• NIH Device Record Key: 60f89ec5-601c-4a77-8f53-aac7302358a1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Corkscrew Electrode
• Version Model Number: 003-400000-6
• Catalog Number: 003-400000-6
• Company DUNS: 499490357
• Company Name: SGM d.o.o.
• Device Count: 6
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 4049445709
• Email: suzy.simic@medical-electrodes.com

Device Dimensions

• Length: 1 Meter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852373007014 [Unit of Use]
GS1	00852373007021 [Primary]
GS1	00852373007038 [Package]; Package: Carton Box [250 Units]; In Commercial Distribution
GS1	00852373007106 [Package]; Package: Carton Box [350 Units]; In Commercial Distribution
GS1	00852373007113 [Package]; Package: Carton Box [100 Units]; In Commercial Distribution
GS1	00852373007182 [Package]; Package: Carton Box [300 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K934779

FDA Product Code

• GXZ: Electrode, Needle

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-23

On-Brand Devices [Corkscrew Electrode ]

• 00852373007212: Corkscrew electrode CS-F (2m) 003-400001-5. Five twisted electrodes in double package to preser
• 00852373007052: Corkscrew Electrode CS-F (1,5m) 003-400001-6. Six packed individual inside one package of 6 to
• 00852373007021: Corkscrew Electrode CS-F (1,0m) 003-400000-6. Six packed individual inside one package to prese