FDA Device Establishments · JSON-LD · Markdown
FEI 3010635845 · Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device · Status: Active
| FEI Number | 3010635845 |
|---|---|
| Owner / Operator | TAKAYAMA INSTRUMENT Inc. (#10050133) |
| Address | 3-4-4 Yanaka, Taito-ku Tokyo, 1100001, JP |
| Mandatory US Agent | Amenichi Consulting, LLC |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | GEA |
| Regulation § (21 CFR) | 878.4800 |
| Proprietary names | SSTi-MY22-029 Cleaning Stylet for MY22 Hand-Piece; SSTi-MY22L SuperBypass Suction-Irrigation MiNi Hand-Piece For Left-Handed Psn; SSTi-01 SuperBypass Suction-Irrigation Hand-Piece; SSTi-SET1L SuperBypass Suction-Irrigation system starter kit 1 For Left-Handed Person (1HP, 4Tips, 2Stylet, 1L-Wnch); SSTi-032 Stylet Insert Cover (2pcs); SSTi-SET1 SuperBypass Suction-Irrigation system starter kit 1 (1 HP, 4 Tips, 2 Stylets, 1 L-Wrench); SSTi-SET-MY22L SuperBypass Suction-Irrigation MiNi system starter kit 1 For Left-Handed Psn (1 HP, 4 Tips, 2 Stylet; SSTi-SET-MY22 SuperBypass Suction-Irrigation MiNi system starter kit 1 (1 HP, 4 Tips, 2 Stylets ,2 Stylet Insert Cover; SSTi-01L SuperBypass Suction-Irrigation Hand-Piece For Left-Handed Person; SSTi-MY22 SuperBypass Suction-Irrigation MiNi Hand-Piece |
Source: openFDA. Public-domain (CC0).