FDA device listing
DiamondTouch Syringe,Hydraulic Assembly,Hydraulic-Master Syringe Assembly,Master Syringe Assembly,Osseoflex Bone Filler…
FDA device listing 1633513564 · Terumo BCT, INC.
Key facts
| Proprietary names | DiamondTouch Syringe,Hydraulic Assembly,Hydraulic-Master Syringe Assembly,Master Syringe Assembly,Osseoflex Bone Filler Device (BFD),Purge Assist,StabiliT Cement Delivery Syringe,X-Change Cement Dispensing Syringe |
|---|---|
| Owner/operator | Terumo BCT, INC. |
| Owner/operator number | 9002708 |
| 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 | Terumo BCT STERILIZATION SERVICES, Inc. |
| Establishment registrations | 1724474 |
| FEI numbers | 3003094851 |
| Establishment operations | Contract Sterilizer |
| 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