MyoTrace 042

GUDID 00816271020827

MyoTrace 400

Noraxon U.S.A., Inc.

Kinesiology/electromyographic sensor set

• Primary Device ID: 00816271020827
• NIH Device Record Key: 34828495-b3f3-4c20-9e2e-b0b32b6f14f6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MyoTrace
• Version Model Number: 042
• Catalog Number: 042
• 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	00816271020827 [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

Devices Manufactured by Noraxon U.S.A., Inc.

• 00816271020070 - Telemyo: 2023-06-15 Telemyo 2400R G2 Analog Output Receiver
• 00816271020315 - Dual EMG Electrodes: 2023-06-15 Wet Ag/AgCl Gel Dual EMG Electrodes 8 pieces per pouch
• 00816271020711 - myoRESEARCH3 (MR3): 2023-06-15 MR3 - myoMUSCLE
• 00816271020742 - myoRESEARCH3 (MR3): 2023-06-15 MR3 - myoMOTION
• 00816271020780 - myoRESEARCH3 (MR3): 2023-06-15 MR3 - myoVIDEO
• 00816271020797 - myoRESEARCH3 (MR3): 2023-06-15 MR3 - myoPRESSURE
• 00816271020827 - MyoTrace: 2023-06-15MyoTrace 400
• 00816271020827 - MyoTrace: 2023-06-15 MyoTrace 400
• 00816271020834 - MyoSystem: 2023-06-15 MyoSystem 1400A