Moisyn Dry Mouth Oral Rinse

GUDID 00852181005141

SYNEDGEN, INC.

Artificial saliva Artificial saliva Artificial saliva Artificial saliva Artificial saliva Artificial saliva Artificial saliva Artificial saliva Artificial saliva Artificial saliva Artificial saliva Artificial saliva Artificial saliva Artificial saliva

• Primary Device ID: 00852181005141
• NIH Device Record Key: c95b6c95-7c38-41e3-9398-a0d35f9d2d35
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Moisyn Dry Mouth Oral Rinse
• Version Model Number: 59.1
• Company DUNS: 830276353
• Company Name: SYNEDGEN, 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: 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: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 855-774-7962
• Email: info@synedgen.com
• Phone: 855-774-7962
• Email: info@synedgen.com
• Phone: 855-774-7962
• Email: info@synedgen.com
• Phone: 855-774-7962
• Email: info@synedgen.com
• Phone: 855-774-7962
• Email: info@synedgen.com
• Phone: 855-774-7962
• Email: info@synedgen.com
• Phone: 855-774-7962
• Email: info@synedgen.com
• Phone: 855-774-7962
• Email: info@synedgen.com
• Phone: 855-774-7962
• Email: info@synedgen.com
• Phone: 855-774-7962
• Email: info@synedgen.com
• Phone: 855-774-7962
• Email: info@synedgen.com
• Phone: 855-774-7962
• Email: info@synedgen.com
• Phone: 855-774-7962
• Email: info@synedgen.com
• Phone: 855-774-7962
• Email: info@synedgen.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852181005141 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173237

FDA Product Code

• LFD: Saliva, Artificial

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: 2020-12-30
• Device Publish Date: 2020-12-22

On-Brand Devices [Moisyn Dry Mouth Oral Rinse]

• 00852181005042: Moisyn is a specifically formulated artificial saliva substitute which contains moistur
• 00852181005141: 59.1
• 00852181005097: Moisyn is a specifically formulated artificial saliva substitute which contains moistur