FDA device listing
Osseoflex Straight Hand Drill,Preston™ Hard Bone Introducer,Preston™ Long Drill,Preston™ Transpedicular Drill,VertecoR…
FDA device listing 1142396868 · Merit Medical Systems, Inc.
Key facts
| Proprietary names | Osseoflex Straight Hand Drill,Preston™ Hard Bone Introducer,Preston™ Long Drill,Preston™ Transpedicular Drill,VertecoR Bone Drill, 3.0 |
|---|---|
| Owner/operator | Merit Medical Systems, Inc. |
| Owner/operator number | 1721504 |
| Product codes | HTW |
| Device names | HTW - Bit, Drill |
| Device class | Class I |
| Classification regulations (21 CFR) | 888.4540 |
| Review panels | Orthopedic |
| Registered establishments | Merit Medical Asia Company Limited, Merit Medical Australia Pty Ltd., Merit Medical Canada Ltd., MERIT MEDICAL IRELAND, LTD, Merit Medical Nederland BV, MERIT MEDICAL SYSTEMS, INC., Merit Medical UK Limited |
| Establishment registrations | 1721504, 9616662, 3006950086, 3012536737, 3015225571, 3015309643, 3033589330 |
| FEI numbers | 1721504, 3000335778, 3006950086, 3012536737, 3015225571, 3015309643, 3033589330 |
| Establishment operations | Contract Manufacturer, Foreign Exporter, 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