FDA device listing
MCS TIP, SP1098, 10 PACK - 430035-11,MCS TIP, SP1098, 10 PACK - 430035-13,SHEATH, SP CAMERA INSTRUMENT, 10 PACK…
FDA device listing 1551596678 · Sotera Health LLC
Key facts
| Proprietary names | MCS TIP, SP1098, 10 PACK - 430035-11,MCS TIP, SP1098, 10 PACK - 430035-13,SHEATH, SP CAMERA INSTRUMENT, 10 PACK - 430020-10,SHEATH, SP CAMERA INSTRUMENT, 10 PACK - 430020-12,SHEATH, SP INSTRUMENT, 15 PACK (30 UNITS) - 430012-14,SHEATH, SP INSTRUMENT, 15 PACK (30 UNITS) - 430012-17,SP1098 Entry Guide - 430022,SP Camera Instrument Sheath - 430020,SP Drape - 430013,SP Instrument Sheath - 430012,SP… |
|---|---|
| Owner/operator | Sotera Health LLC |
| Owner/operator number | 10029425 |
| Product codes | NAY |
| Device names | NAY - System, Surgical, Computer Controlled Instrument |
| Device class | Class II |
| Classification regulations (21 CFR) | 876.1500 |
| Review panels | Gastroenterology & Urology |
| Registered establishments | Sterigenics Costa Rica S.R.L., Sterigenics U.S., LLC, Sterigenics US LLC |
| Establishment registrations | 1058584, 1721686, 2011171, 2022435, 2029015, 3004111573, 3010432890 |
| FEI numbers | 1721686, 2011171, 2022435, 1000160458, 1000219637, 3004111573, 3010432890 |
| 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