FDA Device Establishments · JSON-LD · Markdown
FEI 3013247477 · Repack or Relabel Medical Device · Status: Active
| FEI Number | 3013247477 |
|---|---|
| Owner / Operator | Arvato SE (#10053073) |
| Address | Werner-Schroeder Str 1, Hamburg, 21035, DE |
| Mandatory US Agent | Gyrus ACMI, Inc. |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | PMU |
| Regulation § (21 CFR) | 884.4050 |
| Proprietary names | Containment system, laparoscopic power morcellation, with instrument port |
Source: openFDA. Public-domain (CC0).