X-Series, X8

GUDID 00850015266553

Dual Lead Cable 40" 3-Pin Kit

ADVANCED BRAIN MONITORING, INC.

Analytical non-scalp cutaneous lead Analytical non-scalp cutaneous lead Analytical non-scalp cutaneous lead Analytical non-scalp cutaneous lead Analytical non-scalp cutaneous lead Analytical non-scalp cutaneous lead Analytical non-scalp cutaneous lead Analytical non-scalp cutaneous lead Analytical non-scalp cutaneous lead Analytical non-scalp cutaneous lead Analytical non-scalp cutaneous lead Analytical non-scalp cutaneous lead Analytical non-scalp cutaneous lead Analytical non-scalp cutaneous lead Analytical non-scalp cutaneous lead Analytical non-scalp cutaneous lead Analytical non-scalp cutaneous lead Analytical non-scalp cutaneous lead Analytical non-scalp cutaneous lead Analytical non-scalp cutaneous lead Analytical non-scalp cutaneous lead Analytical non-scalp cutaneous lead Analytical non-scalp cutaneous lead Analytical non-scalp cutaneous lead Analytical non-scalp cutaneous lead Analytical non-scalp cutaneous lead Analytical non-scalp cutaneous lead Analytical non-scalp cutaneous lead Analytical non-scalp cutaneous lead Analytical non-scalp cutaneous lead Analytical non-scalp cutaneous lead Analytical non-scalp cutaneous lead Analytical non-scalp cutaneous lead Analytical non-scalp cutaneous lead Analytical non-scalp cutaneous lead Analytical non-scalp cutaneous lead Analytical non-scalp cutaneous lead Analytical non-scalp cutaneous lead Analytical non-scalp cutaneous lead Analytical non-scalp cutaneous lead Analytical non-scalp cutaneous lead Analytical non-scalp cutaneous lead Analytical non-scalp cutaneous lead Analytical non-scalp cutaneous lead Analytical non-scalp cutaneous lead Analytical non-scalp cutaneous lead Analytical non-scalp cutaneous lead Analytical non-scalp cutaneous lead Analytical non-scalp cutaneous lead

• Primary Device ID: 00850015266553
• NIH Device Record Key: e8b08403-c1af-4d11-bc58-294ed33c926c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: X-Series, X8
• Version Model Number: UN03-4008
• Company DUNS: 969842715
• Company Name: ADVANCED BRAIN MONITORING, INC.
• 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850015266553 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131383

FDA Product Code

• GWQ: Full-Montage Standard Electroencephalograph

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-11-23
• Device Publish Date: 2022-11-15

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