FDA device listing
Parietex Composite Mesh (PCO and PCO-OS references),Parietex Optimized Composite Mesh (PCO-X, PCO-FX and PCO-OSX…
FDA device listing 1226151856 · SANMED MEDIKAL OTOMOTIV TEKSTIL TICARET LIMITED SIRKETI
Key facts
| Proprietary names | Parietex Composite Mesh (PCO and PCO-OS references),Parietex Optimized Composite Mesh (PCO-X, PCO-FX and PCO-OSX references),Parietex Surgical Mesh (modified into Parietex Hydrophilic 2D, 3D, Anatomical Mesh),Parietex Surgical Mesh (modified into Parietex Hydrophilic 2D, 3D, Anatomical Mesh), |
|---|---|
| Owner/operator | SANMED MEDIKAL OTOMOTIV TEKSTIL TICARET LIMITED SIRKETI |
| Owner/operator number | 10089530 |
| Premarket submissions | K173796 |
| Product codes | FTL |
| Device names | FTL - Mesh, Surgical, Polymeric |
| Device class | Class II |
| Classification regulations (21 CFR) | 878.3300 |
| Review panels | General & Plastic Surgery |
| Registered establishments | SANMED MEDIKAL OTOMOTIV TEKSTIL TICARET LIMITED SIRKETI |
| Establishment registrations | 3014479313 |
| FEI numbers | 3014479313 |
| Establishment operations | Foreign Exporter |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes 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