FDA device listing
Double Pump Day Cassette,Double Pump Patient Cassette,Double Pump RF Patient Cassette,Double Pump Single
FDA device listing 1363601051 · SteriPack Asia Sdn Bhd
Key facts
| Proprietary names | Double Pump Day Cassette,Double Pump Patient Cassette,Double Pump RF Patient Cassette,Double Pump Single |
|---|---|
| Owner/operator | SteriPack Asia Sdn Bhd |
| Owner/operator number | 10043162 |
| Product codes | HRX |
| Device names | HRX - Arthroscope |
| Device class | Class II |
| Classification regulations (21 CFR) | 888.1100 |
| Review panels | Orthopedic |
| Registered establishments | STERIPACK ASIA SDN BHD |
| Establishment registrations | 3009988302 |
| FEI numbers | 3009988302 |
| 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