FDA device listing
Asepsis Caps,Drapes,DRAPES Sterile,Foot Switch Drapes,INTRABEAM Drape,INTRABEAM SMARTDRAPE,OPMI Drape,OPMI Drape…
FDA device listing 1100744125 · Carl Zeiss Meditec AG (Jena)
Key facts
| Proprietary names | Asepsis Caps,Drapes,DRAPES Sterile,Foot Switch Drapes,INTRABEAM Drape,INTRABEAM SMARTDRAPE,OPMI Drape,OPMI Drape Sterile,SMARTDRAPE,SMARTDRAPE Replacement Lenses,VisionGuard Lens Protectors,VisionGuard Replacement Lenses |
|---|---|
| Owner/operator | Carl Zeiss Meditec AG (Jena) |
| Owner/operator number | 9053564 |
| Product codes | PUI |
| Device names | PUI - Drape, Surgical, Exempt |
| Device class | Class II |
| Classification regulations (21 CFR) | 878.4370 |
| Review panels | General & Plastic Surgery |
| Registered establishments | CARL ZEISS MEDITEC AG (OBERKOCHEN) |
| Establishment registrations | 9615010 |
| FEI numbers | 3003481798 |
| Establishment operations | Manufacturer, 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