M-Scan

GUDID 00860003499962

M-Scan is specifically designed to record craniofacial muscle activity during function and resting.

Bio-Research Associates, Inc.

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• Primary Device ID: 00860003499962
• NIH Device Record Key: e7a8a9b5-5ef5-41bf-bbe5-1cba8fd77da1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: M-Scan
• Version Model Number: Clench
• Company DUNS: 063501373
• Company Name: Bio-Research Associates, 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: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 4145534334
• Email: info@bioresearchinc.com
• Phone: 4145534334
• Email: info@bioresearchinc.com
• Phone: 4145534334
• Email: info@bioresearchinc.com
• Phone: 4145534334
• Email: info@bioresearchinc.com
• Phone: 4145534334
• Email: info@bioresearchinc.com
• Phone: 4145534334
• Email: info@bioresearchinc.com
• Phone: 4145534334
• Email: info@bioresearchinc.com
• Phone: 4145534334
• Email: info@bioresearchinc.com
• Phone: 4145534334
• Email: info@bioresearchinc.com
• Phone: 4145534334
• Email: info@bioresearchinc.com
• Phone: 4145534334
• Email: info@bioresearchinc.com
• Phone: 4145534334
• Email: info@bioresearchinc.com
• Phone: 4145534334
• Email: info@bioresearchinc.com
• Phone: 4145534334
• Email: info@bioresearchinc.com
• Phone: 4145534334
• Email: info@bioresearchinc.com
• Phone: 4145534334
• Email: info@bioresearchinc.com
• Phone: 4145534334
• Email: info@bioresearchinc.com
• Phone: 4145534334
• Email: info@bioresearchinc.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860003499962 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130158

FDA Product Code

• KZM: Device, Muscle Monitoring

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: 2023-06-30
• Device Publish Date: 2023-06-22

On-Brand Devices [M-Scan]

• 00860003499962: M-Scan is specifically designed to record craniofacial muscle activity during function and resti
• 00860003499955: M-Scan is specifically designed to record craniofacial muscle activity during function and resti