FDA device listing
PI-104; TAUT INTRACUDERS 10/bx 8FR X 3.5,PI-128; TAUT INTRADUCERS 10/BX 10FR x 8,TAUT CHOLANG CATH10/BOX 4.5 FRX 18,TAUT…
FDA device listing 1217256373 · Sotera Health LLC
Key facts
| Proprietary names | PI-104; TAUT INTRACUDERS 10/bx 8FR X 3.5,PI-128; TAUT INTRADUCERS 10/BX 10FR x 8,TAUT CHOLANG CATH10/BOX 4.5 FRX 18,TAUT CHOLANG CATH10/BX 4.5 FR TIP X 18,TAUT CHOLANG CATH10/BX 4.5 FR TIP X 30,TAUT CHOLANG CATH10/BX 4.5FRx30 no MST,TAUT CHOLANG CATH10/BX 5.5 FR TIP X 18,TAUT CHOLANG CATH10/BX 5.5 FR X 18,TAUT CHOLANG CATH10/BX 6.5 FR TIP X 18,TAUT CHOLANG CATH10/BX 6.5 FR X 18,TAUT CHOLANG… |
|---|---|
| Owner/operator | Sotera Health LLC |
| Owner/operator number | 10029425 |
| Product codes | GCJ |
| Device names | GCJ - Laparoscope, General & Plastic Surgery |
| Device class | Class II |
| Classification regulations (21 CFR) | 876.1500 |
| Review panels | Gastroenterology & Urology |
| Registered establishments | Sterigenics U.S., LLC, Sterigenics US LLC |
| Establishment registrations | 1420032, 3002907620 |
| FEI numbers | 1420032, 3002907620 |
| Establishment operations | Contract Sterilizer |
| 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