FDA device listing
Merit1383(TM) - Introducer Needle with Trocar Stylet,,Merit1383 (TM) - Mak-NV,PFMMedical6614 (TM) - 4F x 10cm ACCEL…
FDA device listing 1458283539 · STERIS Corporation
Key facts
| Proprietary names | Merit1383(TM) - Introducer Needle with Trocar Stylet,,Merit1383 (TM) - Mak-NV,PFMMedical6614 (TM) - 4F x 10cm ACCEL Centesis Catheter Percutaneous Fluid Drainage (Ref 613211),PFMMedical6614 (TM) - 4F x 10cm Jet-Vac Centesis Catheter (Ref M7512),PFMMedical6614 (TM) - 4F x 10cm Jet-Vac Procedure Tray (Ref M7852),PFMMedical6614 (TM) - 4F x 10cm Jet-Vac Safety Procedure Tray (Ref M7552),PFMMedical6614… |
|---|---|
| Owner/operator | STERIS Corporation |
| Owner/operator number | 1527821 |
| Product codes | GCB |
| Device names | GCB - Needle, Catheter |
| Device class | Class I |
| Classification regulations (21 CFR) | 878.4200 |
| Review panels | General & Plastic Surgery |
| Registered establishments | Isomedix Operations, Inc., ISOMEDIX OPERATIONS INC. |
| Establishment registrations | 1220477, 2030624 |
| FEI numbers | 1220477, 3000206435 |
| 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