FDA device listing
Bonding Cement,Skin Tac H Liquid Adhesive
FDA device listing 1566767479 · Safetec of America Inc
Key facts
| Proprietary names | Bonding Cement,Skin Tac H Liquid Adhesive |
|---|---|
| Owner/operator | Safetec of America Inc |
| Owner/operator number | 9006898 |
| Product codes | EZR |
| Device names | EZR - Cement, Stomal Appliance, Ostomy |
| Device class | Class I |
| Classification regulations (21 CFR) | 876.5900 |
| Review panels | Gastroenterology & Urology |
| Registered establishments | SAFETEC OF AMERICA, INC. |
| Establishment registrations | 1319744 |
| FEI numbers | 1000159898 |
| 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