EVOKED POTENTIAL SYSTEM 2 EP-SYS2

GUDID 00811478012422

ELECTRO-CAP INTERNATIONAL INC

Analytical scalp lead

• Primary Device ID: 00811478012422
• NIH Device Record Key: ffd768cf-471a-458f-864f-af33300eb9cb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EVOKED POTENTIAL SYSTEM 2
• Version Model Number: EP-SYS2
• Catalog Number: EP-SYS2
• Company DUNS: 186765806
• Company Name: ELECTRO-CAP INTERNATIONAL INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 18005272193
• Email: eci@electro-cap.com
• Phone: 18005272193
• Email: eci@electro-cap.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00811478012422 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112319

FDA Product Code

• GXY: Electrode, Cutaneous

Sterilization

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

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

Devices Manufactured by ELECTRO-CAP INTERNATIONAL INC

• 00811478010213 - NEEDLE/SYRINGE KIT - LARGE: 2020-12-16
• 00811478011883 - ELECTRO-GEL 16oz: 2018-10-22
• 00811478011890 - ELECTRO-GEL 32oz: 2018-10-22
• 00811478011906 - ELECTRO-GEL 128OZ: 2018-10-22
• 00811478011913 - ELECTRO-GEL 16OZ. BOXED: 2018-10-22
• 00811478011920 - ELECTRO-GEL 32 OZ. BOXED: 2018-10-22
• 00811478010008 - CAP W/AG/AGCL ELECTRODES: 2018-07-06
• 00811478010015 - SPECIAL CAP: 2018-07-06