FDA device listing
Universa Firm Ureteral Stent and Positioner with Hydrophilic Coating,Universa Firm Ureteral Stent and Positioner with…
FDA device listing 1131853221 · COOK, INC.
Key facts
| Proprietary names | Universa Firm Ureteral Stent and Positioner with Hydrophilic Coating,Universa Firm Ureteral Stent and Positioner with Hydrophilic Coating and Monofilament Tether,Universa Firm Ureteral Stent Set with Hydrophilic Coating,Universa Firm Ureteral Stent Set with Hydrophilic Coating and Monofilament Tether |
|---|---|
| Owner/operator | COOK, INC. |
| Owner/operator number | 1820334 |
| Premarket submissions | K161236 |
| Product codes | FAD |
| Device names | FAD - Stent, Ureteral |
| Device class | Class II |
| Classification regulations (21 CFR) | 876.4620 |
| Review panels | Gastroenterology & Urology |
| Registered establishments | Cook Incorporated, COOK INCORPORATED |
| Establishment registrations | 1820334, 1825146, 1000393132 |
| FEI numbers | 1820334, 1825146, 1000393132 |
| Establishment operations | Complaint File Establishment, Contract Sterilizer, Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 100–999 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