FDA device listing
AMPLATZ SUPER STIFF GUIDE WIRE 80 CM - 536037JR,ANGEL- II TWO EDGE FLEXIBLE NITINOL GUIDE WIRE 0.035 X 150cm…
FDA device listing 1335031998 · Plasti-med Plastik Medikal Urunler San. ve Tic. Ltd. Sti.
Key facts
| Proprietary names | AMPLATZ SUPER STIFF GUIDE WIRE 80 CM - 536037JR,ANGEL- II TWO EDGE FLEXIBLE NITINOL GUIDE WIRE 0.035 X 150cm - 536038,ANGEL PTFE - NITINOL GUIDEWIRE WITH HYDROPHILIC TIP 0.035 X 150cm - 536023,ANGEL PTFE - NITINOL GUIDEWIRE WITH HYDROPHILIC TIP 0.038 X 150cm - 536024,GUIDE WIRE 0.018 x 150 CM (STRAIGHT TIP) - 536025,GUIDE WIRE 0.025 x 150 CM (STRAIGHT TIP) - 536026,GUIDE WIRE 0.025 x 150 CM… |
|---|---|
| Owner/operator | Plasti-med Plastik Medikal Urunler San. ve Tic. Ltd. Sti. |
| Owner/operator number | 10080023 |
| Product codes | OCY |
| Device names | OCY - Endoscopic Guidewire, Gastroenterology-Urology |
| Device class | Class II |
| Classification regulations (21 CFR) | 876.1500 |
| Review panels | Gastroenterology & Urology |
| Registered establishments | PLASTI-MED PLASTIK MEDIKAL URUNLER SAN. VE TIC. LTD. STI. |
| Establishment registrations | 3018762668 |
| FEI numbers | 3018762668 |
| Establishment operations | 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