Tether Extension Cable Male-to-Male 3m 31-0613-0031

GUDID 00850011306307

The Tether Extension Cable Male-to-Male 3m is a component of the ATLAS Neurophysiology System.

NEURALYNX, INC.

Electrical-only medical device connection cable, reusable

• Primary Device ID: 00850011306307
• NIH Device Record Key: 84284415-35f5-4a57-a36d-54721a136e50
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tether Extension Cable Male-to-Male 3m
• Version Model Number: 3 meter
• Catalog Number: 31-0613-0031
• 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

Customer Support Contacts

• Phone: 4065854542
• Email: support@neuralynx.com
• Phone: 4065854542
• Email: support@neuralynx.com
• Phone: 4065854542
• Email: support@neuralynx.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850011306307 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110967

FDA Product Code

• IKD: Cable, Electrode

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: 2026-02-27
• Device Publish Date: 2026-02-19

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• 00850011306307 - Tether Extension Cable Male-to-Male 3m: 2026-02-27The Tether Extension Cable Male-to-Male 3m is a component of the ATLAS Neurophysiology System.
• 00850011306307 - Tether Extension Cable Male-to-Male 3m: 2026-02-27 The Tether Extension Cable Male-to-Male 3m is a component of the ATLAS Neurophysiology System.
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• 00850011306703 - ATLAS Stim Headbox Software: 2025-06-19 Control software for the ATLAS Stim Headbox.
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