Comfort Tape

Basic Information

• Brand Name: Comfort Tape
• Primary DI: 00850035489086
• Version / Model: 850035489086
• Catalog Number: 0RN0007-01
• Company Name: Orthonu LLC
• Labeler DUNS: 125732548
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-04-27
• Public Version: 1
• Public Version Date: 2025-05-05
• Public Version Status: New
• Public Device Record Key: fb2789e5-f39c-40dd-ab5b-6aab296c49f2

Device Description

A compound intended to be used as a protective cover for the general mucosa to treat irritated gingiva and sensitive teeth.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NAE	Dressing, Wound, Hydrogel Without Drug And/Or Biologic	General, Plastic Surgery	878.4022	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47943	General oral wound dressing, non-animal-derived	A compound intended to be used as a protective cover for the general oral mucosa to treat mouth wounds and sores such as ulcers and lesions caused by trauma, surgery, radiotherapy/chemotherapy or dental prostheses/orthodontic braces; it may in addition be intended to treat mucosal irritations/inflammation, dryness, and/or gingivitis, or to prevent mouth wounds/lesions. It consists primarily of one or more plant-derived and/or (bio)synthetic compound(s) [e.g., polysaccharides, hyaluronic acid, dimethicone] and is supplied in various forms (e.g., plug, sheet, gel, fluid, spray) for use in the home and clinical setting. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850035489086	GS1
Previous	00199284539792	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]