Indicator, Chemical, Enzymatic, Sterilization Process

Device Code: 2689

Product Code(s): MTC

Device Classification Information

• Device Type ID: 2689
• Device Name: Indicator, Chemical, Enzymatic, Sterilization Process
• Regulation Description: Sterilization Process Indicator.
• Regulation Medical Specialty: General Hospital
• Review Panel: General Hospital
• Premarket Review: Office Of Device Evaluation (ODE); Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID); General Hospital Devices Branch (GHDB)
• Submission Type: 510(k)
• CFR Regulation Number: 880.2800 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: MTC
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Eligible For Accredited Persons Expansion Pilot Program

Recognized Standards

• 14-334 ISO 15882 Second Edition 2008-09-01
  Sterilization Of Health Care Products - Chemical Indicators - Guidance For Selection, Use And Interpretation Of Results
• 14-460 ISO 11140-1 Third Edition 2014-11-01
  Sterilization Of Health Care Products - Chemical Indicators - Part 1: General Requirements

Total Product Life Cycle

• Device Type ID: 2689
• Device: Indicator, Chemical, Enzymatic, Sterilization Process
• Product Code: MTC
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Sterilization Process Indicator.
• CFR Regulation Number: 880.2800 [🔎]

TPLC Last Update: 2019-04-02 20:17:26