EMA Custom

GUDID 00842326101142

EMA CAD Disc, 98mm x 18mm thick, opaque

The Myerson Company Limited

Mandible-repositioning sleep-disordered breathing orthosis

• Primary Device ID: 00842326101142
• NIH Device Record Key: c6741428-3549-487a-b2e9-b074b3f42228
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EMA Custom
• Version Model Number: EMADISC-NTL-9818
• 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: true
• 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
• 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 Dimensions

• Height: 18 Millimeter
• Outer Diameter: 98 Millimeter
• Height: 18 Millimeter
• Outer Diameter: 98 Millimeter
• Height: 18 Millimeter
• Outer Diameter: 98 Millimeter
• Height: 18 Millimeter
• Outer Diameter: 98 Millimeter
• Height: 18 Millimeter
• Outer Diameter: 98 Millimeter
• Height: 18 Millimeter
• Outer Diameter: 98 Millimeter
• Height: 18 Millimeter
• Outer Diameter: 98 Millimeter
• Height: 18 Millimeter
• Outer Diameter: 98 Millimeter
• Height: 18 Millimeter
• Outer Diameter: 98 Millimeter
• Height: 18 Millimeter
• Outer Diameter: 98 Millimeter
• Height: 18 Millimeter
• Outer Diameter: 98 Millimeter
• Height: 18 Millimeter
• Outer Diameter: 98 Millimeter
• Height: 18 Millimeter
• Outer Diameter: 98 Millimeter
• Height: 18 Millimeter
• Outer Diameter: 98 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842326101142 [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: 2020-09-30
• Device Publish Date: 2020-09-22

On-Brand Devices [EMA Custom]

• 00842326101159: EMA CAD Disc, 98mm x 18mm thick, blue
• 00842326101142: EMA CAD Disc, 98mm x 18mm thick, opaque