MyoSystem 210

GUDID 00816271020834

MyoSystem 1400A

Noraxon U.S.A., Inc.

Kinesiology/electromyographic sensor set

• Primary Device ID: 00816271020834
• NIH Device Record Key: af0e4733-ddf0-444e-9f01-aab92ee0c70d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MyoSystem
• Version Model Number: 210
• Catalog Number: 210
• Company DUNS: 611243809
• Company Name: Noraxon U.S.A., Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816271020834 [Primary]

FDA Product Code

• HCC: Device, Biofeedback

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: 2023-06-15
• Device Publish Date: 2023-06-07

On-Brand Devices [MyoSystem]

• 00816271020841: MyoSystem 1400L
• 00816271020834: MyoSystem 1400A