FDA Device Establishments · JSON-LD · Markdown
FEI 3013992977 · Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device · Status: Active
| FEI Number | 3013992977 |
|---|---|
| Owner / Operator | OTU MEDICAL INC. (#10058788) |
| Address | 2847A Whipple Rd., Union City, CA, US |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | FAJ |
| Regulation § (21 CFR) | 876.1500 |
| Proprietary names | WiScope® Single-Use Digital Flexible Cystoscope; WiScope® Medical Tablet; WiScope® Image System; Aptra Single-Use Digital Flexible Cystoscope; Aptra Digital Cystoscope System; Aptra Image System; WiScope® Digital Cystoscope System |
Source: openFDA. Public-domain (CC0).