FDA device listing
Y201B ENDOSCOPIC TOOL SET - OBTURATOR,Y202B ENDOSCOPIC TOOL SET - CANNULA,Y211A ENDOSCOPIC TOOL SET - OBTURATOR…
FDA device listing 1700030030 · Straits Orthopaedics (Mfg) Sdn Bhd
Key facts
| Proprietary names | Y201B ENDOSCOPIC TOOL SET - OBTURATOR,Y202B ENDOSCOPIC TOOL SET - CANNULA,Y211A ENDOSCOPIC TOOL SET - OBTURATOR, ROUND,Y212A ENDOSCOPIC TOOL SET - CANNULA, ROUND |
|---|---|
| Owner/operator | Straits Orthopaedics (Mfg) Sdn Bhd |
| Owner/operator number | 10048319 |
| Product codes | GEA |
| Device names | GEA - Cannula, Surgical, General & Plastic Surgery |
| Device class | Class I |
| Classification regulations (21 CFR) | 878.4800 |
| Review panels | General & Plastic Surgery |
| Registered establishments | STRAITS ORTHOPAEDICS (MFG) SDN BHD |
| Establishment registrations | 3025603301, 3033509898, 3036756245 |
| FEI numbers | 3025603301, 3033509898, 3036756245 |
| Establishment operations | Contract 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