Dynarex L-Mesitran Soft

Basic Information

• Brand Name: Dynarex L-Mesitran Soft
• Primary DI: 00616784307831
• Version / Model: 3078
• Company Name: DYNAREX CORPORATION
• Labeler DUNS: 008124539
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 24
• Record Status: Published
• Publish Date: 2019-06-03
• Public Version: 3
• Public Version Date: 2022-12-05
• Public Version Status: Update
• Public Device Record Key: 0c4e9c1e-556d-4d01-8b05-2dfaee746836

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): Yes
• 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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
FRO	Dressing, Wound, Drug	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
47773	Medical honey liquid barrier dressing	A material formed from medical grade honey intended to protect wounds or tissue surfaces by providing a non-occlusive external barrier to bacteria and the environment. It also helps to maintain a moist internal environment for wounds to assist the healing process. The material may be liquid or semi-liquid and is typically applied directly to the wound or tissue surface (e.g., ocular surface). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00616784307831	GS1
Unit of Use	00616784307824	GS1

Premarket Submissions

Submission Number	Supplement Number
K150676	000