FDA device listing
Above Table Attachment for Single Pivot Swing Arm Drape,Double Pivot Swing Arm Drape (DRP2000),Mobile Barrier with Torso…
FDA device listing 1024675791 · Burlington Medical LLC
Key facts
| Proprietary names | Above Table Attachment for Single Pivot Swing Arm Drape,Double Pivot Swing Arm Drape (DRP2000),Mobile Barrier with Torso Cutout,Mobile Leaded Barrier with 10" W x 12" H Window,Mobile Leaded Barrier with 30" W x 48" H Window,Mobile Porta Shield,Single Pivot Swing Arm Drape (DRP1000),T-Base Porta Shield PTS4 |
|---|---|
| Owner/operator | Burlington Medical LLC |
| Owner/operator number | 10049248 |
| Product codes | EAK |
| Device names | EAK - Screen, Leaded, Operator Radiation Protector |
| Device class | Class I |
| Classification regulations (21 CFR) | 892.6500 |
| Review panels | Radiology |
| Registered establishments | BURLINGTON MEDICAL, LLC |
| Establishment registrations | 1222742 |
| FEI numbers | 1000120804 |
| Establishment operations | Manufacturer, Repackager/Relabeler |
| 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