FDA device listing
AXIOM CLOSED WOUND,Axiom(R),Axiom(R) CWV with Trocar,Axiom(R) Facial Drain with Trocar,Axiom(R) Flat Closed Wound Drain…
FDA device listing 1778229884 · AXIOM MEDICAL, INC.
Key facts
| Proprietary names | AXIOM CLOSED WOUND,Axiom(R),Axiom(R) CWV with Trocar,Axiom(R) Facial Drain with Trocar,Axiom(R) Flat Closed Wound Drain With Trocar,Axiom(R) Petite(R) Wound Drain,Axiom(R) Petite(R) Wound Drainage Kit,Axiom(R) Petite(R) Wound Drainage Sytstem,Axiom(R) Round Closed Wound Drain With Trocar,Axiom(R) SeroVac(R) |
|---|---|
| Owner/operator | AXIOM MEDICAL, INC. |
| Owner/operator number | 2020735 |
| Product codes | GBX |
| Device names | GBX - Catheter, Irrigation |
| Device class | Class I |
| Classification regulations (21 CFR) | 878.4200 |
| Review panels | General & Plastic Surgery |
| Registered establishments | AXIOM MEDICAL, INC. |
| Establishment registrations | 2020735 |
| FEI numbers | 2020735 |
| Establishment operations | 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