FDA device listing
Vitale Cover Dressing,Vitale Hydroconductive Dressings,Vitale Silicone Super Absorbent Dressings,Vitale STRONG Calcium…
FDA device listing 1537465065 · CellEra, LLC
Key facts
| Proprietary names | Vitale Cover Dressing,Vitale Hydroconductive Dressings,Vitale Silicone Super Absorbent Dressings,Vitale STRONG Calcium Alginate Dressings,Vitale STRONG Gelling Fiber Dressings |
|---|---|
| Owner/operator | CellEra, LLC |
| Owner/operator number | 10029252 |
| Product codes | NAC, PFP |
| Device names | NAC - Dressing, Wound, Hydrophilic, PFP - Silicone Hydrogel For Scar Management |
| Device class | Class I |
| Classification regulations (21 CFR) | 878.4018, 878.4025 |
| Review panels | General & Plastic Surgery |
| Registered establishments | CellEra, LLC, NANJING 3H MEDICAL PRODUCTS CO.,LTD. |
| Establishment registrations | 3007594734, 3007607706 |
| FEI numbers | 3007594734, 3007607706 |
| Establishment operations | Complaint File Establishment, 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