FDA device listing

Indicator, Physical/Chemical Sterilization Process

FDA device listing 1964043067 · STERIS Corporation

Key facts

Owner/operator STERIS Corporation
Owner/operator number 10078069
Premarket submissions K240760
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 STERIS Corporation, STERIS CORPORATION
Establishment registrations 3000251274, 3004080920
FEI numbers 3000251274, 3004080920
Establishment operations Repackager/Relabeler, 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