FDA device listing
Surgical Marking Pen
FDA device listing 1880661139 · OASIS MEDICAL, INC.
Key facts
| Proprietary names | Surgical Marking Pen |
|---|---|
| Owner/operator | OASIS MEDICAL, INC. |
| Owner/operator number | 2083373 |
| Product codes | FZZ |
| Device names | FZZ - Marker, Skin |
| Device class | Class I |
| Classification regulations (21 CFR) | 878.4660 |
| Review panels | General & Plastic Surgery |
| Registered establishments | Oasis Medical, Inc., OASIS MEDICAL, INC. |
| Establishment registrations | 2083373, 3006234743 |
| FEI numbers | 2083373 |
| Establishment operations | Complaint File Establishment, Specification Developer, Repackager/Relabeler |
| 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