FDA device listing
AMD-Ritmed Gown,AMD-Ritmed Isolation Gown,AMD-Ritmed Lab Coat,AMD-Ritmed Lab Jacket,Medicom SafeBasics Gown,Medicom…
FDA device listing 1333129017 · Medicom Group
Key facts
| Proprietary names | AMD-Ritmed Gown,AMD-Ritmed Isolation Gown,AMD-Ritmed Lab Coat,AMD-Ritmed Lab Jacket,Medicom SafeBasics Gown,Medicom SafeWear Gown,Medicom SafeWear Jacket,Medicom SafeWear Lab Coat,Ritmed Gown |
|---|---|
| Owner/operator | Medicom Group |
| Owner/operator number | 8020405 |
| Product codes | OEA |
| Device names | OEA - Non-Surgical Gown |
| Device class | Class I |
| Classification regulations (21 CFR) | 878.4040 |
| Review panels | General & Plastic Surgery |
| Registered establishments | AMD Medicom Inc. |
| Establishment registrations | 9611959 |
| FEI numbers | 3002677549 |
| Establishment operations | Complaint File Establishment, Foreign Exporter, Specification Developer |
| 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