FDA device listing
K053321 Light, Surgical, Accessories,Light Guard Rigid 1/pkg Sterile,Light Guard Rigid 2/pkg Sterile - (40 packs of…
FDA device listing 1864554762 · Sotera Health LLC
Key facts
| Proprietary names | K053321 Light, Surgical, Accessories,Light Guard Rigid 1/pkg Sterile,Light Guard Rigid 2/pkg Sterile - (40 packs of 2),Light Handle Cover 1/pkg,Light Handle Cover 2/pkg,Light Handle Cover 3/pkg,Medichoice Light Handle Cover (80 Packs of 2). Light Handle: 60512,Medichoice Light Handle Cover Light Handle Cover 60513 3/pk 64 pk/case Sterile,Medichoice Light Handle Cvr Light Handle Cover 60511 1/pk… |
|---|---|
| Owner/operator | Sotera Health LLC |
| Owner/operator number | 10029425 |
| Product codes | FTA |
| Device names | FTA - Light, Surgical, Accessories |
| Device class | Class II |
| Classification regulations (21 CFR) | 878.4580 |
| Review panels | General & Plastic Surgery |
| Registered establishments | Sterigenics U.S., LLC, Sterigenics US, LLC |
| Establishment registrations | 1018470, 1420032, 1526534 |
| FEI numbers | 1018470, 1420032, 1526534 |
| 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