FDA device listing
RUSCH MMG/O'NEIL CATHETER
FDA device listing 1411048213 · Khtp Sterilisation Services Sdn. Bhd.
Key facts
| Proprietary names | RUSCH MMG/O'NEIL CATHETER |
|---|---|
| Owner/operator | Khtp Sterilisation Services Sdn. Bhd. |
| Owner/operator number | 10085005 |
| Product codes | FCM, KOD |
| Device names | FCM - Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit), KOD - Catheter, Urological |
| Device class | Class II |
| Classification regulations (21 CFR) | 876.5130 |
| Review panels | Gastroenterology & Urology |
| Registered establishments | KHTP STERILISATION SERVICES SDN. BHD. |
| Establishment registrations | 3022518300 |
| FEI numbers | 3022518300 |
| Establishment operations | Contract Sterilizer |
| 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