FDA device listing
Skin On Skin Dressing Kit - SOS1400,Skin- On- Skin - SOS1048 & SOS1200
FDA device listing 1256820371 · MEDI-DYNE HEALTHCARE PRODUCTS, LTD
Key facts
| Proprietary names | Skin On Skin Dressing Kit - SOS1400,Skin- On- Skin - SOS1048 & SOS1200 |
|---|---|
| Owner/operator | MEDI-DYNE HEALTHCARE PRODUCTS, LTD |
| Owner/operator number | 9054275 |
| Product codes | NAE |
| Device names | NAE - Dressing, Wound, Hydrogel Without Drug And/Or Biologic |
| Device class | Class I |
| Classification regulations (21 CFR) | 878.4022 |
| Review panels | General & Plastic Surgery |
| Registered establishments | MEDI-DYNE HEALTHCARE PRODUCTS, INC. |
| Establishment registrations | 3003175285 |
| FEI numbers | 3003175285 |
| Establishment operations | 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