EMA Now

GUDID 00842326101173

Trays only

The Myerson Company Limited

Mandible-repositioning sleep-disordered breathing orthosis

• Primary Device ID: 00842326101173
• NIH Device Record Key: 435498cd-ba99-4745-8455-d4999718f647
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EMA Now
• Version Model Number: EMANOWTR
• Company DUNS: 857278431
• Company Name: The Myerson Company Limited
• 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

Customer Support Contacts

• Phone: 18004232683
• Email: orders@myersontooth.com
• Phone: 18004232683
• Email: orders@myersontooth.com
• Phone: 18004232683
• Email: orders@myersontooth.com
• Phone: 18004232683
• Email: orders@myersontooth.com
• Phone: 18004232683
• Email: orders@myersontooth.com
• Phone: 18004232683
• Email: orders@myersontooth.com
• Phone: 18004232683
• Email: orders@myersontooth.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842326101173 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K971794

FDA Product Code

• LRK: Device, Anti-Snoring

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: 2021-07-27
• Device Publish Date: 2021-07-19

On-Brand Devices [EMA Now]

• 00842326101180: Special EMA NOW strap assortment
• 00842326101173: Trays only
• 00842326101166: Full kit with all components