FDA device listing
laparoscopic gastrostomy kit
FDA device listing 1001096879 · O & M Halyard, Inc.
Key facts
| Proprietary names | laparoscopic gastrostomy kit |
|---|---|
| Owner/operator | O & M Halyard, Inc. |
| Owner/operator number | 10039033 |
| Product codes | PSD |
| Device names | PSD - Laparoscopic Gastrostomy Kit |
| Device class | Class II |
| Classification regulations (21 CFR) | 876.5980 |
| Review panels | Gastroenterology & Urology |
| Registered establishments | AVID MEDICAL, INC. A MEDICAL ACTION IND. COMPANY 305, MEDICAL ACTION INDUSTRIES, INC. 306 |
| Establishment registrations | 1030451, 1047429 |
| FEI numbers | 1030451, 1047429 |
| 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