FDA Device Establishments · JSON-LD · Markdown
FEI 3010966701 · Manufacture Medical Device for Another Party (Contract Manufacturer) · Status: Active
| FEI Number | 3010966701 |
|---|---|
| Owner / Operator | CUSTOM TUBE MANUFACTURING LLC (#10046953) |
| Address | 38-4, Hyeonseok-ro 733beon-gil, Gwangjeok-myeon, Yangju-si Gyeonggi, 11413, KR |
| Mandatory US Agent | SPECTRA MEDICAL DEVICES, LLC |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | FCG |
| Regulation § (21 CFR) | 876.1075 |
| Proprietary names | TRUGUIDE COAXIAL BIOPSY NEEDLE; BLUNT TIP STYLET FOR TRUGUIDE NEEDLE |
Source: openFDA. Public-domain (CC0).