FDA device listing
10MM 0° AUTOCLAVABLE BARIATRIC LAPAROSCOPE, 45CM,10MM 0° BARIATRIC LAPAROSCOPE, AC,10MM 30° AUTOCLAVABLE BARIATRIC…
FDA device listing 1662498083 · HENKE-SASS WOLF, GMBH.
Key facts
| Proprietary names | 10MM 0° AUTOCLAVABLE BARIATRIC LAPAROSCOPE, 45CM,10MM 0° BARIATRIC LAPAROSCOPE, AC,10MM 30° AUTOCLAVABLE BARIATRIC LAPAROSCOPE, 45CM,10MM 30° BARIATRIC LAPAROSCOPE, AC,10MM 45° AUTOCLAVABLE BARIATRIC LAPAROSCOPE, 45CM,10MM 45° BARIATRIC LAPAROSCOPE, AC,5MM 30° BARIATRIC LAPAROSCOPE, AC,HD 10MM 0 DEGREES BARIATRIC IR LAPARSCOPE, AC,HD 10MM 30 DEGREES BARIATRIC IR LAPARSCOPE, AC,HD 10MM 45… |
|---|---|
| Owner/operator | HENKE-SASS WOLF, GMBH. |
| Owner/operator number | 8010418 |
| 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 | HENKE-SASS WOLF, GMBH. |
| Establishment registrations | 8010418 |
| FEI numbers | 3007130719 |
| Establishment operations | Contract 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