FDA device listing
S-MAK
FDA device listing 1177854728 · Merit Medical Systems, Inc.
Key facts
| Proprietary names | S-MAK |
|---|---|
| Owner/operator | Merit Medical Systems, Inc. |
| Owner/operator number | 1721504 |
| Product codes | DRE |
| Device names | DRE - Dilator, Vessel, For Percutaneous Catheterization |
| Device class | Class II |
| Classification regulations (21 CFR) | 870.1310 |
| Review panels | Cardiovascular |
| Registered establishments | Merit Maquiladora Mexico, S. DE R.L. DE C.V., Merit Medical Asia Company Limited, Merit Medical Australia Pty Ltd., Merit Medical Canada Ltd., Merit Medical Nederland BV, Merit Medical UK Limited |
| Establishment registrations | 3006950086, 3011642792, 3012536737, 3015225571, 3015309643, 3033589330 |
| FEI numbers | 3006950086, 3011642792, 3012536737, 3015225571, 3015309643, 3033589330 |
| Establishment operations | Foreign Exporter |
| 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