Axonpen

GUDID 00860000321303

Axonpen Endoscope

Clearmind Biomedical Inc.

Surgical irrigation/aspiration cannula, illuminating, single-use

• Primary Device ID: 00860000321303
• NIH Device Record Key: 9bf4bc14-4894-4553-8188-8536e2d6016a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Axonpen
• Version Model Number: AH-50-110
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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	00860000321303 [Primary]
GS1	10860000321300 [Package]; 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: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-02-16
• Device Publish Date: 2022-02-08

Devices Manufactured by Clearmind Biomedical Inc.

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