FDA device listing
Accessories, Photographic, For Endoscope (Exclude Light Sources)
FDA device listing 1751876675 · ARTHREX, INC.
Key facts
| Proprietary names | Accessories, Photographic, For Endoscope (Exclude Light Sources) |
|---|---|
| Owner/operator | ARTHREX, INC. |
| Owner/operator number | 1220287 |
| Product codes | FEM |
| Device names | FEM - Accessories, Photographic, For Endoscope (Exclude Light Sources) |
| Device class | Class I |
| Classification regulations (21 CFR) | 876.1500 |
| Review panels | Gastroenterology & Urology |
| Registered establishments | Arthrex Colombia SAS, Arthrex, Inc., ARTHREX, INC., Arthrex Logistic Center Canada |
| Establishment registrations | 1220246, 3010331645, 3021226419, 3030926959 |
| FEI numbers | 1220246, 3010331645, 3021226419, 3030926959 |
| Establishment operations | Contract Manufacturer, Contract Sterilizer, Foreign Exporter, Specification Developer |
| 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