Zipshield 10m 31-0604-0129

GUDID 00850011306970

This product contains a full conductive metal plated cloth inner shield with a durable plastic outer jacket which is easily applied over one or more ATLAS Tether cables providing both noise shielding and cable management.

NEURALYNX, INC.

Facility radio-frequency shielding material

• Primary Device ID: 00850011306970
• NIH Device Record Key: 2025de63-8eae-4582-b87f-f3a9b4a0f955
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Zipshield 10m
• Version Model Number: 10m
• Catalog Number: 31-0604-0129
• Company DUNS: 933200842
• Company Name: NEURALYNX, 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• 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	00850011306970 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110967

FDA Product Code

• OMC: Reduced- 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: 2024-12-19
• Device Publish Date: 2024-12-11

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• 00850011306703 - ATLAS Stim Headbox Software: 2025-06-19 Control software for the ATLAS Stim Headbox.
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• 00850011306727 - Fiber Optic Connector 7m: 2025-06-19 Computer ethernet connection; 7m in length.
• 00850011306901 - ATLAS Headbox Interface Cable - Touchproof: 2025-06-19 Cable to connect 100-pin Hirose connector to Touchproof pins.
• 00850011306918 - ATLAS Headbox Interface Cable - NK: 2025-06-19 Cable to connect 100-pin Hirose connector to NK connector.
• 00850011306925 - ATLAS Headbox Interface Cable - High Density: 2025-06-19 Cable to connect 100-pin Hirose connector to Natus connector.