Indicator, Sterilization

Device Code: 2662

Product Code(s): LRT

Device Classification Information

• Device Type ID: 2662
• Device Name: Indicator, Sterilization
• 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: LRT
• 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

• 14-332 ISO 11140-5 Second Edition 2007-03-15
  Sterilization Of Health Care Products - Chemical Indicators - Part 5: Class 2 Indicators For Bowie And Dick-type Air Removal Tests
• 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: 2662
• Device: Indicator, Sterilization
• Product Code: LRT
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Sterilization Process Indicator.
• CFR Regulation Number: 880.2800 [🔎]

TPLC Last Update: 2019-04-02 20:16:55