FDA device listing
MEDCOMP BREEZE Biliary Drain with Locking Pigtail Set,MEDCOMP BREEZE Biliary Drain without Locking Pigtail Set
FDA device listing 1728395192 · BIOTEQUE CORP
Key facts
| Proprietary names | MEDCOMP BREEZE Biliary Drain with Locking Pigtail Set,MEDCOMP BREEZE Biliary Drain without Locking Pigtail Set |
|---|---|
| Owner/operator | BIOTEQUE CORP |
| Owner/operator number | 9038266 |
| Premarket submissions | K210419 |
| Product codes | FGE, GBO |
| Device names | FGE - Stents, Drains And Dilators For The Biliary Ducts, GBO - Catheter, Nephrostomy, General & Plastic Surgery |
| Device class | Class I, Class II |
| Classification regulations (21 CFR) | 876.5010, 878.4200 |
| Review panels | Gastroenterology & Urology, General & Plastic Surgery |
| Registered establishments | BIOTEQUE CORP., Bioteque Corporation I-Lan Factory II, Bioteque Corporation Yilan Science Park Factory |
| Establishment registrations | 3004207966, 3012480535, 3035451914 |
| FEI numbers | 3004207966, 3012480535, 3035451914 |
| Establishment operations | Complaint File Establishment, Foreign Exporter, Manufacturer |
| 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