Oil Emulsion Dressing

Basic Information

• Brand Name: Oil Emulsion Dressing
• Primary DI: 00616784306711
• Version / Model: 3067
• Company Name: DYNAREX CORPORATION
• Labeler DUNS: 008124539
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-06-21
• Public Version: 2
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: 0c6187eb-6289-42a1-8bc1-2940c5de4849

Device Description

Oil Emulsion Dressing, 3"x3", Non-Adherent

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: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	878.4020	1

GMDN Terms

Code	Name	Definition	Implantable	Status
57966	Pressure-ulcer topical dressing	A solution or emulsion designed to be applied to dermal pressure sores to prevent and treat pressure/decubitus ulcers and lower extremity ulcers. It is composed of natural materials (e.g., ozonized olive oil, sunflower oil, and/or other plant extracts) intended primarily to create a barrier between the skin lesion(s) and the external environment to promote protection and healing. The solution/emulsion is typically dispensed from a spray bottle or other container. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00616784306728	GS1	Box	50	In Commercial Distribution
Primary	00616784306711	GS1
Package	00616784306735	GS1	Case	4	In Commercial Distribution