FDA device listing
ZeniCol Collagen Dressing
FDA device listing 1447302475 · Focus Health Group
Key facts
| Proprietary names | ZeniCol Collagen Dressing |
|---|---|
| Owner/operator | Focus Health Group |
| Owner/operator number | 10060699 |
| Premarket submissions | K213598 |
| Product codes | KGN |
| Device names | KGN - Wound Dressing With Animal-Derived Material(S) |
| Device class | Unclassified |
| Classification regulations (21 CFR) | ORCA1.KGN |
| Review panels | General & Plastic Surgery |
| Registered establishments | FOCUS HEALTH GROUP |
| Establishment registrations | 3006802076 |
| FEI numbers | 3006802076 |
| Establishment operations | Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes 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