ClearPath

GUDID 00860000321341

ClearPath Disposable Introducer

Clearmind Biomedical Inc.

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• Primary Device ID: 00860000321341
• NIH Device Record Key: c1d400c9-de88-4fc5-9f04-7e01ba7afae8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ClearPath
• Version Model Number: AK-19-110
• 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: false
• 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	00860000321334 [Primary]
GS1	00860000321341 [Package]; Contains: 00860000321334; Package: Box [5 Units]; In Commercial Distribution
GS1	00860000321358 [Package]; Package: Carton [8 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210251

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

Devices Manufactured by Clearmind Biomedical Inc.

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