FDA device listing
Kolibri Direct Puncture Sets,Kolibri Percutaneous Nephrostomy Catheters,Kolibri Percutaneous Nephrostomy Kits
FDA device listing 1180206725 · Coloplast Corp.
Key facts
| Proprietary names | Kolibri Direct Puncture Sets,Kolibri Percutaneous Nephrostomy Catheters,Kolibri Percutaneous Nephrostomy Kits |
|---|---|
| Owner/operator | Coloplast Corp. |
| Owner/operator number | 8010144 |
| Premarket submissions | K211911 |
| Product codes | FAD, LJE |
| Device names | FAD - Stent, Ureteral, LJE - Catheter, Nephrostomy |
| Device class | Class II, Unclassified |
| Classification regulations (21 CFR) | 876.4620, ORCA1.LJE |
| Review panels | Gastroenterology & Urology |
| Registered establishments | Centre de distribution Coloplast Le Plessis Pate, COLOPLAST HUNGARY KFT, COLOPLAST MANUFACTURING FRANCE, SAS, Coloplast Manufacturing US, LLC. |
| Establishment registrations | 9610711, 3003814961, 3012649202, 3030087693 |
| FEI numbers | 3002807917, 3003814961, 3012649202, 3030087693 |
| Establishment operations | Foreign Exporter, Manufacturer, Repackager/Relabeler |
| 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