Axonpen System

GUDID 10860000321317

Axonbox

Clearmind Biomedical Inc.

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• Primary Device ID: 10860000321317
• NIH Device Record Key: 846916d3-1f64-48c7-8cd8-bf8e6f252f2f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Axonpen System
• Version Model Number: AH-50-210
• Company DUNS: 658832644
• Company Name: Clearmind Biomedical 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: 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	00860000321310 [Primary]
GS1	10860000321317 [Package]; Contains: 00860000321310; Package: Carton [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201308

FDA Product Code

• GWG: Endoscope, Neurological

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: 2022-02-28
• Device Publish Date: 2022-02-18

Devices Manufactured by Clearmind Biomedical Inc.

• 10860000321317 - Axonpen System: 2022-02-28Axonbox
• 10860000321317 - Axonpen System: 2022-02-28 Axonbox
• 00860000321341 - ClearPath: 2022-02-28 ClearPath Disposable Introducer
• 00860000321303 - Axonpen: 2022-02-16 Axonpen Endoscope