FDA device listing
Balfour abdominal retractor 170mm,Balfour abdominal retractor 250mm,Gosset Baby Retractor,Gosset Retractor large,Gosset…
FDA device listing 2048050426 · Schobell Industrial Ltda
Key facts
| Proprietary names | Balfour abdominal retractor 170mm,Balfour abdominal retractor 250mm,Gosset Baby Retractor,Gosset Retractor large,Gosset Retractor medium,Gosset Retractor small,KIDNEY TRANSPLANT RETRACTOR QUINELATO,Mathieu rectal specula 19cm,Millin Retractor, 4 valves,Pitanga Santos Anoscope,Pitanga Santos Anoscope n. 01 19x85mm,Pitanga Santos Anoscope n. 02 22x85mm,Pitanga Santos Anoscope n. 03 25x85mm,Sims… |
|---|---|
| Owner/operator | Schobell Industrial Ltda |
| Owner/operator number | 10059048 |
| Product codes | FFO |
| Device names | FFO - Retractor, Self-Retaining |
| Device class | Class I |
| Classification regulations (21 CFR) | 876.4730 |
| Review panels | Gastroenterology & Urology |
| Registered establishments | SCHOBELL INDUSTRIAL LTDA |
| Establishment registrations | 5906 |
| FEI numbers | 5906 |
| Establishment operations | Manufacturer |
| 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