Materials

• Embossed PE Film

Product Attributes

• Circular fenestration
• Adhesive tape for secure placement

Sterilization

Sterile: Sterilized by EO (ethylene oxide). Product is sterile unless the package has been damaged or opened. Non-Sterile: If a product is delivered non-sterile and is ultimately for use in sterile environments, it is intended to be sterilized by the repackager. This includes further packaging and sterilization according to the validated processes of the re-packager. These products are to be sterilized by ethylene oxide (EO). Other methods of sterilization have not been validated by Meve.
Shelf Life

Sterile: 5 years
Non-Sterile: Established at 5 years based upon sterile packaged
product aging studies and normal warehouse storage conditions.
After 5 years, the product should be performance tested to ensure
compliance to specifications

Product Certifications/Standards

• • CE certified as Class I, according to MDR 2017/745 Annex VIII, Rule 1
• US FDA: Class II

Manufacturing Certifications/Registrations

• EN ISO 13485:2016
• Medical Device Single Audit Process Certified

Storage

• General warehouse conditions