FDA device listing
VERIFY Bowie Dick Test Pack (EQC009) (HP-MF, LC-MF)
FDA device listing 1359779721 · STERIS Corporation
Key facts
| Proprietary names | VERIFY Bowie Dick Test Pack (EQC009) (HP-MF, LC-MF) |
|---|---|
| Owner/operator | STERIS Corporation |
| Owner/operator number | 10078069 |
| Premarket submissions | K002741 |
| 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 |
| 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