ACS-789/82R

GUDID 03664539003900

GUIDE FOR Ø 2.45MM ACCESSORIES ACCESSORY OF MICRODEEP DEPTH ELECTRODE

DIXI MEDICAL

Depth electrode Depth electrode Depth electrode Depth electrode Depth electrode Depth electrode Depth electrode Depth electrode Depth electrode Depth electrode Depth electrode Depth electrode Depth electrode Depth electrode Depth electrode Depth electrode Depth electrode

• Primary Device ID: 03664539003900
• NIH Device Record Key: 2628a9ed-8c9d-44cc-a14f-e284e02c8f42
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: INSTRUMENT GUIDE
• Catalog Number: ACS-789/82R
• Company DUNS: 268009609
• Company Name: DIXI MEDICAL
• Device Count: 1
• DM Exempt: true
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +33381889890
• Email: info@diximedical.com
• Phone: +33381889890
• Email: info@diximedical.com
• Phone: +33381889890
• Email: info@diximedical.com
• Phone: +33381889890
• Email: info@diximedical.com
• Phone: +33381889890
• Email: info@diximedical.com
• Phone: +33381889890
• Email: info@diximedical.com
• Phone: +33381889890
• Email: info@diximedical.com
• Phone: +33381889890
• Email: info@diximedical.com
• Phone: +33381889890
• Email: info@diximedical.com
• Phone: +33381889890
• Email: info@diximedical.com
• Phone: +33381889890
• Email: info@diximedical.com
• Phone: +33381889890
• Email: info@diximedical.com
• Phone: +33381889890
• Email: info@diximedical.com
• Phone: +33381889890
• Email: info@diximedical.com
• Phone: +33381889890
• Email: info@diximedical.com
• Phone: +33381889890
• Email: info@diximedical.com
• Phone: +33381889890
• Email: info@diximedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	03664539003900 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170959

FDA Product Code

• GZL: Electrode, Depth

Sterilization

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

[03664539003900]

Moist Heat or Steam Sterilization

[03664539003900]

Moist Heat or Steam Sterilization

[03664539003900]

Moist Heat or Steam Sterilization

[03664539003900]

Moist Heat or Steam Sterilization

[03664539003900]

Moist Heat or Steam Sterilization

[03664539003900]

Moist Heat or Steam Sterilization

[03664539003900]

Moist Heat or Steam Sterilization

[03664539003900]

Moist Heat or Steam Sterilization

[03664539003900]

Moist Heat or Steam Sterilization

[03664539003900]

Moist Heat or Steam Sterilization

[03664539003900]

Moist Heat or Steam Sterilization

[03664539003900]

Moist Heat or Steam Sterilization

[03664539003900]

Moist Heat or Steam Sterilization

[03664539003900]

Moist Heat or Steam Sterilization

[03664539003900]

Moist Heat or Steam Sterilization

[03664539003900]

Moist Heat or Steam Sterilization

[03664539003900]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-04-11
• Device Publish Date: 2024-04-03

Devices Manufactured by DIXI MEDICAL

• 03664539003900 - NA: 2024-04-11GUIDE FOR Ø 2.45MM ACCESSORIES ACCESSORY OF MICRODEEP DEPTH ELECTRODE
• 03664539003900 - NA: 2024-04-11 GUIDE FOR Ø 2.45MM ACCESSORIES ACCESSORY OF MICRODEEP DEPTH ELECTRODE
• 03664539003917 - NA: 2024-04-11 GUIDE FOR Ø 2.45MM ACCESSORIES ACCESSORY OF MICRODEEP DEPTH ELECTRODE
• 03664539003870 - NA: 2023-04-11 SEEG DEPTH ELECTRODE, 6 MACRO AND 12 MICRO-CONTACTS PROXIMAL, EXPLORATION LENGTH 34, Ø 0.8MM
• 03664539003887 - NA: 2023-04-11 SEEG DEPTH ELECTRODE, 6 MACRO AND 12 MICRO-CONTACTS PROXIMAL, EXPLORATION LENGTH 42, Ø 0.8MM
• 03664539003894 - NA: 2023-04-11 SEEG DEPTH ELECTRODE, 6 MACRO AND 12 MICRO-CONTACTS PROXIMAL, EXPLORATION LENGTH 50, Ø 0.8MM
• 03664539003696 - NA: 2022-10-18 SET OF 10 ANCHOR BOLTS, LENGTH 25MM, LENGTH OF THE SELF-TAPPING THREAD 10MM ACCESSORY OF MICRODEEP DEPTH ELECTRODE
• 03664539003702 - NA: 2022-10-18 "SET OF 10 ANCHOR BOLTS, LENGTH 30MM, LENGTH OF THE SELF-TAPPING THREAD 10MM ACCESSORY OF MICRODEEP DEPTH ELECTRODE"
• 03664539003719 - NA: 2022-10-18 "SET OF 10 ANCHOR BOLTS, LENGTH 35MM,LENGTH OF THE SELF-TAPPING THREAD 10MM ACCESSORY OF MICRODEEP DEPTH ELECTRODE"