FDA Device Establishments · JSON-LD · Markdown
FEI 3008776287 · Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device · Status: Active
| FEI Number | 3008776287 |
|---|---|
| Owner / Operator | STERIS Corporation (#10078069) |
| Address | 503 Canal Blvd, ad, Richmond, CA, US |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | FTA |
| Regulation § (21 CFR) | 878.4580 |
| Proprietary names | Harmony iQ 2800-SLC (RM-CFE); Sterile Light Handle Cover (MG-SD, RO-RR); Universal Light Handle Cover (MG-SD, RO-RR); Sterile Handle Camera Cover (MG-SD, RO-RR); IDSS-SLC (version 7 and 8) (RM-CFE); Harmony iQ 2400-SLC (RM-CFE); Harmony iQ 3600-SLC (RM-CFE); HexaVue Focus Integration System-Surgical Light Control (RM-MF); HexaVue IP In-Light Control Systems (RM-MF) |
Source: openFDA. Public-domain (CC0).