FDA Device Establishments · JSON-LD · Markdown
FEI 3012414760 · Remanufacture Medical Device · Status: Active
| FEI Number | 3012414760 |
|---|---|
| Owner / Operator | HOYA Corporation PENTAX Division (#8030235) |
| Address | 6715 Millcreek Drive, Unit 1, Mississauga Ontario, L5N 5V2, CA |
| Mandatory US Agent | HOYA CORPORATION PENTAX DIVISION |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | FDF |
| Regulation § (21 CFR) | 876.1500 |
| Proprietary names | VIDEO COLONOSCOPE (EC38-i10NF-OUS); DISTAL RUBBER HOOD (OE-A59); VIDEO COLONOSCOPE - CLASSIC LINE (EC-380LKP); FIBEROPTIC COLONOSCOPE (FC-38LV-OUS); VIDEO COLONOSCOPE (EC34-I10TL); VIDEO COLONOSCOPE (EC38-i10NL-OUS); VIDEO COLONOSCOPE - PTAH (EC38-V10CL-OUS); VIDEO COLONOSCOPE - PTAH (EC38-V10CM-OUS); VIDEO COLONOSCOPE (EC34-I10CL-OUS); IMAGINA VENTING CAP (OE-C28) |
Source: openFDA. Public-domain (CC0).