FDA device listing
HEMC MACKINTOSH SHEETING
FDA device listing 1268866971 · HOSPITAL EQUIPMENT MFG. CO.
Key facts
| Proprietary names | HEMC MACKINTOSH SHEETING |
|---|---|
| Owner/operator | HOSPITAL EQUIPMENT MFG. CO. |
| Owner/operator number | 9008836 |
| Product codes | EYX |
| Device names | EYX - Drape, Pure Latex Sheet, With Self-Retaining Finger Cot |
| Device class | Class II |
| Classification regulations (21 CFR) | 878.4370 |
| Review panels | General & Plastic Surgery |
| Registered establishments | HOSPITAL EQUIPMENT MFG. CO. |
| Establishment registrations | 9680411 |
| FEI numbers | 3008205331 |
| Establishment operations | Manufacturer |
| 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