FDA Device Establishments · JSON-LD · Markdown
FEI 3004857851 · Manufacture Medical Device · Status: Active
| FEI Number | 3004857851 |
|---|---|
| Owner / Operator | HISTO S.A. (#9067502) |
| Address | AV. GRAL. PAZ 315, VILLA RAFFO Buenos Aires, 1674, AR |
| Mandatory US Agent | Oceanside RC&T LLC |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | DWO |
| Regulation § (21 CFR) | 878.4800 |
| Proprietary names | Biocore II FULL Automatic Soft Tissue Biopsy Needles Code 881820; Mamawire Breast Localization Needles Code 212012; Biocore II FULL Automatic Soft Tissue Biopsy Needles Code 881815; Biocore II TC Semi Automatic Soft Tissue Biopsy Needles Code 771625; Biocore II FULL Automatic Soft Tissue Biopsy Needles Code 881825; Mamawire Plus Breast Localization Needles Code 312013; Biocore II BR Soft Tissue Biopsy Needles Code 661415; Biocore II MG C Soft Tissue Biopsy Needles Code 551220C; Biocore II FULL Automatic Soft Tissue Biopsy Needles Code 881813; Biocore II MG Soft Tissue Biopsy Needles Code 551830 |
Source: openFDA. Public-domain (CC0).