Emu-Graph 4 Emulator, Model Ci 144

• • Terminated Z-1531-2010 FDA Unclassified (pre-2012) ·initiated 15 Jul 2009

  This action notifies affected SteriTec customers as well as private label distributors of the necessity to modify the shelf life of their sterilization indicator products. There is insufficient data on file to support the shelf life dating on the product labeling.

510(k) Number

K083650 ↗

FDA Product Code

JOJ

Device Class

Class II

Regulation

21 CFR Part 880.2800

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Steritec Container Cord - Ci 135, Steritec Process Indicator Labels - Ci 140, Steritec Process Indicator Dots - Ci 137

  Class II

  FDA 510(k) K052516 Active Cleared 3 Oct 2005

• Cross-Checks Lf, Model Ci 119/S &Ci 119/L

  Class II

  FDA 510(k) K003533 Active Cleared 7 Feb 2001

• Verrix EVA™ STEAM Biological Indicator (BI) (Model: 1200), Verrix EVA™ STEAM Process Challenge Device (PCD) (Model: 1300) combined with Verrix EVA™ Auto-Reader (Model: 1100)

  Class II

  FDA 510(k) K252306 Active Cleared 22 Apr 2026

• Eo Gas Sterilization Process Indicator Tapes, Model Ci 124

  Class II

  FDA 510(k) K002861 Active Cleared 29 Nov 2000

• Steritec Autoclave Tapes, Model CI122 & CI1234

  Class II

  FDA 510(k) K001649 Active Cleared 23 Jun 2000

• Bowie-Dick Mini Pak, Model Bd 115

  Class II

  FDA 510(k) K024293 Active Cleared 11 Aug 2003

See all devices from Steritec Products, Inc. →