Product Classification

• Device: sterilization wrap containers, trays, cassettes & other accessories
• Regulation Description: Sterilization wrap.
• Regulation Medical Specialty: General Hospital
• Review Panel: General Hospital
• Product Code: KCT
• Submission Type: 510(k)
• Regulation Number: 880.6850
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standard

• AAMI/ANSI ST77:2006/(R)2010 Containment devices for reusable medical device sterilization

Third Party Review

• Eligible for Accredited Persons Expansion Pilot Program

Accredited Persons

• dekra certification b.v.
• intertek testing services
• regulatory technology services, llc
• tuv sud america inc.
• underwriters laboratories, inc.