FDA device listing
NU-IP40D SONY IP Converter,NU-IP40S SONY IP Converter,NU-NM10B SONY Network System Manager,NU-NM11B SONY Network System…
FDA device listing 1252882710 · Sony Corporation
Key facts
| Proprietary names | NU-IP40D SONY IP Converter,NU-IP40S SONY IP Converter,NU-NM10B SONY Network System Manager,NU-NM11B SONY Network System Manager |
|---|---|
| Owner/operator | Sony Corporation |
| Owner/operator number | 9078461 |
| Premarket submissions | K161122 |
| Product codes | GCJ |
| Device names | GCJ - Laparoscope, General & Plastic Surgery |
| Device class | Class II |
| Classification regulations (21 CFR) | 876.1500 |
| Review panels | Gastroenterology & Urology |
| Registered establishments | Sony Corporation, Sony Global Manufacturing & Operations Corporation Kohda Site |
| Establishment registrations | 3004091527, 3016527960 |
| FEI numbers | 3004091527, 3016527960 |
| Establishment operations | Complaint File Establishment, Specification Developer, Contract Manufacturer |
| 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