FDA device listing

VERIFY SixCess 270F 4 Challenge Pack (LCC003) (HP-MF, LC-SD),VERIFY SixCess 275F 3 Challenge Pack (LCC014) (HP-MF…

FDA device listing 1909347972 · STERIS Corporation

Key facts

Proprietary names VERIFY SixCess 270F 4 Challenge Pack (LCC003) (HP-MF, LC-SD),VERIFY SixCess 275F 3 Challenge Pack (LCC014) (HP-MF, LC-SD)
Owner/operator STERIS Corporation
Owner/operator number 10078069
Premarket submissions K070895
Product codes JOJ
Device names JOJ - Indicator, Physical/Chemical Sterilization Process
Device class Class II
Classification regulations (21 CFR) 880.2800
Review panels General Hospital
Registered establishments ALBERT BROWNE LTD., STERIS Corporation
Establishment registrations 8021896, 3000251274
FEI numbers 3000251274, 3001168737
Establishment operations Manufacturer, Specification Developer
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • 1–9 UDI devices (GUDID) under the same submission
  • 1–9 Device listings citing the same submission
  • Yes Premarket submission listed

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device listings

Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.

Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database

Browse all FDA device listings