FDA device listing
Trufill N-Butyl Cyanoacrylate (N-Bca) Liquid Embolic System
FDA device listing 1628201802 · Medos International SARL
Key facts
| Proprietary names | Trufill N-Butyl Cyanoacrylate (N-Bca) Liquid Embolic System |
|---|---|
| Owner/operator | Medos International SARL |
| Owner/operator number | 10031083 |
| Premarket submissions | P990040 |
| Product codes | KGG, SGU |
| Device names | KGG - Tissue Adhesive For Use In Embolization Of Brain Arteriovenous Malformations, SGU - Neurovascular Liquid Embolic Agent |
| Device class | Class III |
| Classification regulations (21 CFR) | ORCA1.KGG, ORCA1.SGU |
| Review panels | Neurology |
| Registered establishments | MEDOS INTERNATIONAL SARL |
| Establishment registrations | 3008114965 |
| FEI numbers | 3008114965 |
| Establishment operations | Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes 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