FDA device listing
Henry Schein Integrator (FP-CM,HP-CM),HENRY SCHEIN MAXITEST INTEGRATORS (FP-CM,HP-CM),K-Dental Indicators…
FDA device listing 1601201563 · STERIS Corporation
Key facts
| Proprietary names | Henry Schein Integrator (FP-CM,HP-CM),HENRY SCHEIN MAXITEST INTEGRATORS (FP-CM,HP-CM),K-Dental Indicators (FP-CM,HP-CM),McKesson Steam Integrator (FP-CM,HP-CM),MCKESSON STERILIZATION INTEGRATOR (FP-CM,HP-CM),Patterson Type 5 (FP-CM,HP-CM),SPS EMULATING INDICATORS (FP-CM,HP-CM),SPS ENSURE (FP-CM,HP-CM),SPS Henry Schein Integrator (FP-CM,HP-CM),SPS INTEGRATORS (FP-CM,HP-CM),SPS SteamPlus Steam… |
|---|---|
| Owner/operator | STERIS Corporation |
| Owner/operator number | 10078069 |
| 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 |
| Establishment registrations | 3000251274, 3007412809 |
| FEI numbers | 3000251274, 3007412809 |
| Establishment operations | Contract Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed 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