FDA device listing
Delta Thermo Elbow,Delta Thermo Hand/Wrist,Delta Thermo Knee,Delta Thermo Memory,Delta Thermo Orthoplast Boot,Delta…
FDA device listing 1343323778 · BSN medical GmbH
Key facts
| Proprietary names | Delta Thermo Elbow,Delta Thermo Hand/Wrist,Delta Thermo Knee,Delta Thermo Memory,Delta Thermo Orthoplast Boot,Delta Thermo Orthoplast Corset,Delta Thermo Thumb,Delta Thermo Wrist,Delta-Xpress Elbow,Delta-Xpress Hand,Delta-Xpress Lower Leg,Delta-Xpress Wrist |
|---|---|
| Owner/operator | BSN medical GmbH |
| Owner/operator number | 9047426 |
| Product codes | NOC |
| Device names | NOC - Splint, Extremity, Non-Inflatable, External, Non-Sterile |
| Device class | Class I |
| Classification regulations (21 CFR) | 878.3910 |
| Review panels | General & Plastic Surgery |
| Registered establishments | BSN Medical GmbH, BSN medical Inc., BSN Medical S.A. de C.V., Essity Distribution B.V. |
| Establishment registrations | 1038963, 9612388, 3017297225, 3017633586 |
| FEI numbers | 1038963, 3003255844, 3017297225, 3017633586 |
| Establishment operations | Complaint File Establishment, Specification Developer, Foreign Exporter, 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