Mouth-Aid ORN0005-01

GUDID 00850035489031

A compound intended to be used as a protective cover for the general mucosa to treat sores and ulcers.

Orthonu LLC

General oral wound dressing, non-animal-derived

• Primary Device ID: 00850035489031
• NIH Device Record Key: bd02cb6d-e5d5-4e9e-90d3-4e7b3ff6fab7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mouth-Aid
• Version Model Number: 850035489031
• Catalog Number: ORN0005-01
• Company DUNS: 125732548
• Company Name: Orthonu LLC
• 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: true
• Lot Batch: true
• Serial Number: true
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00199284797581 [Previous]
GS1	00850035489031 [Primary]

FDA Product Code

• NAE: Dressing, Wound, Hydrogel Without Drug And/Or Biologic

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: 2025-05-05
• Device Publish Date: 2025-04-27

On-Brand Devices [Mouth-Aid]

• 00199284797581: A compound intended to be used as a protective cover for the general mucosa to treat sores and u
• 00850035489031: A compound intended to be used as a protective cover for the general mucosa to treat sores and u