D08-12AM

GUDID 03664539000077

SEEG DEPTH ELECTRODE, 12 CONTACTS, EXPLORATION LENGTH 40.5MM, Ø 0.8MM, LONG LENGTH

DIXI MEDICAL

Depth electrode

• Primary Device ID: 03664539000077
• NIH Device Record Key: c8e72987-b84e-40dd-8df8-7abd6210c672
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: MICRODEEP DEPTH ELECTRODE
• Catalog Number: D08-12AM
• Company DUNS: 268009609
• Company Name: DIXI MEDICAL
• 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: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• 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 Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
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• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	03664539000077 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170959

FDA Product Code

• GZL: Electrode, Depth

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-09-23
• Device Publish Date: 2017-12-14

Devices Manufactured by DIXI MEDICAL

• 03664539004037 - NA: 2024-10-01 SUBDURAL ELECTRODE WITH CONNECTION CABLE, STRIP, 1x4 CONTACTS
• 03664539004044 - NA: 2024-10-01 SUBDURAL ELECTRODE WITH CONNECTION CABLE, STRIP, 1x6 CONTACTS
• 03664539004051 - NA: 2024-10-01 SUBDURAL ELECTRODE WITH CONNECTION CABLE, STRIP, 1x8 CONTACTS
• 03664539004068 - NA: 2024-10-01 SUBDURAL ELECTRODE WITH CONNECTION CABLE, GRID, 2x4 CONTACTS
• 03664539004075 - NA: 2024-10-01 SUBDURAL ELECTRODE WITH CONNECTION CABLE, GRID, 2x6 CONTACTS
• 03664539004082 - NA: 2024-10-01 SUBDURAL ELECTRODE WITH CONNECTION CABLE, GRID, 2x8 CONTACTS
• 03664539004099 - NA: 2024-10-01 SUBDURAL ELECTRODE WITH CONNECTION CABLE, GRID, 4x4 CONTACTS
• 03664539003900 - NA: 2024-04-11 GUIDE FOR Ø 2.45MM ACCESSORIES ACCESSORY OF MICRODEEP DEPTH ELECTRODE