FDA Device Establishments · JSON-LD · Markdown
FEI 3038718997 · Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device · Status: Active
| FEI Number | 3038718997 |
|---|---|
| Owner / Operator | YorLabs, Inc. (#10094268) |
| Address | 2210 Faraday Ave Ste 100, Carlsbad, CA, US |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 4 |
| Product codes (top 20) | IYN, IYO, OBJ, ITX |
| Regulation § (21 CFR) | 892.1550, 892.1560, 870.1200, 892.1570 |
| Proprietary names | XC11 Communication Hub, USA; XC11 ICE Catheter (2D), USA; XC11 ICE System Tablet, USA; XC11 ICE Box Ultrasound System, USA; XC11 ICE System Disposable Knob, USA; XC11 ICE System, USA; XC11 ICE System Cart, USA; XC11 ICE System Handle, USA |
Source: openFDA. Public-domain (CC0).