Itus Mouthguardz

GUDID 00860002336596

Anti-snore mouthpiece

Shinrin-Yoku Traders LLC

Breathing mouthpiece, reusable

• Primary Device ID: 00860002336596
• NIH Device Record Key: a318ba29-7fb4-4a44-99b4-561ed1991c65
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Itus Mouthguardz
• Version Model Number: SilentZPro 2.0 (with clips, medium)
• Company DUNS: 117177695
• Company Name: Shinrin-Yoku Traders LLC
• 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: false
• Serial Number: false
• Manufacturing Date: true
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860002336596 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220688

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: 2025-09-02
• Device Publish Date: 2025-08-25

On-Brand Devices [Itus Mouthguardz]

• 00860002336565: Anti-snore mouthpiece
• 00860002336558: Anti-snore mouthpiece
• 00860002336503: Anti-snore mouthpiece
• 00860002336572: Anti-snore mouthpiece
• 00860002336596: Anti-snore mouthpiece