FDA device listing
Dressing, Wound, Hydrogel Without Drug And/Or Biologic
FDA device listing 1479934668 · Cardinal Health 200, LLC
Key facts
| Owner/operator | Cardinal Health 200, LLC |
|---|---|
| Owner/operator number | 9028292 |
| Premarket submissions | K952945 |
| Product codes | NAE |
| Device names | NAE - Dressing, Wound, Hydrogel Without Drug And/Or Biologic |
| Device class | Class I |
| Classification regulations (21 CFR) | 878.4022 |
| Review panels | General & Plastic Surgery |
| Registered establishments | Cardinal Health, Cardinal Health 200, LLC, Cardinal Health C/O Avarto Benelux BV |
| Establishment registrations | 1219103, 1423537, 1921846, 3014656668 |
| FEI numbers | 1921846, 1000148701, 3001236905, 3014656668 |
| Establishment operations | Complaint File Establishment, Foreign Exporter, Manufacturer, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None 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