FDA Device Establishments · JSON-LD · Markdown
FEI 3003377038 · Manufacture Medical Device · Status: Active
| FEI Number | 3003377038 |
|---|---|
| Owner / Operator | GE HealthCare Technologies Inc. (#9912004) |
| Address | CALLE ESPANA No. 300, PARQUE INDUSTRIAL HUINALA, APODACA Nuevo Leon, C.P.66645, MX |
| Mandatory US Agent | GE HealthCare Technologies, Inc |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | IYB |
| Regulation § (21 CFR) | 892.1770 |
| Proprietary names | Tubestand (Model: GCTS-C11); OVERHEAD TUBE SUSPENSION (OTS) (Model: 5135678-8); OVERHEAD TUBE SUSPENSION (OTS) (Model: 5135678-9); OVERHEAD TUBE SUSPENSION (OTS for Definium Tempo Pro and Definium Tempo) (Model: 5822306); OVERHEAD TUBE SUSPENSION (OTS) (Model: 5135678-10); OVERHEAD TUBE SUSPENSION (OTS for Definium Tempo Pro and Definium Tempo) (Model: 5822306-1); Tubestand (Model: GCTS-C1); OVERHEAD TUBE SUSPENSION (OTS) (Model: 5135678-7); OVERHEAD TUBE SUSPENSION (OTS for Discovery XR656 HD) (Model: 5135678-11) |
Source: openFDA. Public-domain (CC0).