FDA device listing
basix Compak Analog Inflation Syringe,basixCompak Inflation Device,basixTAU,basixTOUCH,basixTOUCH40 Inflation…
FDA device listing 1939471930 · Sotera Health LLC
Key facts
| Proprietary names | basix Compak Analog Inflation Syringe,basixCompak Inflation Device,basixTAU,basixTOUCH,basixTOUCH40 Inflation Syringe,BIG60,Nellix |
|---|---|
| Owner/operator | Sotera Health LLC |
| Owner/operator number | 10029425 |
| Product codes | PTM |
| Device names | PTM - Syringe, Balloon Inflation, Exempt |
| Device class | Class II |
| Classification regulations (21 CFR) | 870.1650 |
| Review panels | Cardiovascular |
| Registered establishments | Sterigenics Belgium (Petit Rechain) SRL, Sterigenics U.S., LLC |
| Establishment registrations | 1721676, 3005941719 |
| FEI numbers | 1721676, 3002807111 |
| 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