FDA device listing
AP 30 DUO (8 Gal DUO lid),AP 30 MONO (8 Gal MONO lid),AP 50 DUO (12 Gal DUO lid),AP 50 MONO (12 Gal MONO lid),AP 5.4…
FDA device listing 1665057384 · Keter Canada, Inc.
Key facts
| Proprietary names | AP 30 DUO (8 Gal DUO lid),AP 30 MONO (8 Gal MONO lid),AP 50 DUO (12 Gal DUO lid),AP 50 MONO (12 Gal MONO lid),AP 5.4 QT,AP 60 DUO (18 Gal DUO lid),AP 60 MONO (18 Gal MONO lid),AP Medical,PBS 12 Lt |
|---|---|
| Owner/operator | Keter Canada, Inc. |
| Owner/operator number | 10045078 |
| Premarket submissions | K071517 |
| Product codes | MMK |
| Device names | MMK - Container, Sharps |
| Device class | Class II |
| Classification regulations (21 CFR) | 880.5570 |
| Review panels | General Hospital |
| Registered establishments | Keter Canada Inc. |
| Establishment registrations | 3010508078 |
| FEI numbers | 3010508078 |
| Establishment operations | Complaint File Establishment, Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 100–999 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