FDA Device Establishments · JSON-LD · Markdown
FEI 3010396722 · Manufacture Medical Device for Another Party (Contract Manufacturer) Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device · Status: Active
| FEI Number | 3010396722 |
|---|---|
| Owner / Operator | Infinitus Medical Technologies LLC (#10044733) |
| Address | 242 South Main St, Suite 214, Holly Springs, NC, US |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | CCX |
| Regulation § (21 CFR) | 868.6820 |
| Proprietary names | The Genesis Bi-Wing AAP arm adduction pad; FPLS-3000-Wing; LUNA Supine Pad SP-3500; ION ESPS Foam insert; The Hadron FPLS" Foam Pad Lift System; The Kyber SSC Retractor assembly; Visiwrap Robotic face protection system; Mizuho Hana Table Pad and Strap PN FPLS-1210SP; AXR-2000 Pressure Management Foam Wedge; Pneuma Hadron FPLS (inflatable assist positioning system) |
Source: openFDA. Public-domain (CC0).