FDA device listing
DiamondTOUCH Syringe,Hydraulic Assembly,Hydraulic-Master Syringe Assembly,Master Syringe Assembly,Osseon Bone Filler…
FDA device listing 1744844353 · Merit Medical Systems, Inc.
Key facts
| Proprietary names | DiamondTOUCH Syringe,Hydraulic Assembly,Hydraulic-Master Syringe Assembly,Master Syringe Assembly,Osseon Bone Filler Device (BFD),Purge Assist,StabiliT Cement Delivery Syringe,X-Change Cement Dispensing Syringe |
|---|---|
| Owner/operator | Merit Medical Systems, Inc. |
| Owner/operator number | 1721504 |
| Product codes | OAR |
| Device names | OAR - Injector, Vertebroplasty (Does Not Contain Cement) |
| Device class | Class I |
| Classification regulations (21 CFR) | 888.4200 |
| Review panels | Orthopedic |
| 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 IRELAND, LTD, Merit Medical Nederland BV, MERIT MEDICAL SYSTEMS, INC., Merit Medical UK Limited |
| Establishment registrations | 1721504, 9616662, 3006950086, 3011642792, 3012536737, 3015225571, 3015309643, 3033589330 |
| FEI numbers | 1721504, 3000335778, 3006950086, 3011642792, 3012536737, 3015225571, 3015309643, 3033589330 |
| Establishment operations | Contract Manufacturer, Manufacturer, Foreign Exporter, Specification Developer |
| 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