FDA Registration
Active
🇺🇸 United States
OptiVantage DH Power Injection System
Reg #: 1518293
·
FEI: 1518293
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Liebel-Flarsheim Company LLC
- Registration Number
- 1518293
- FEI Number
- 1518293
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 2111 EAST GALBRAITH RD.
- City
- Cincinnati
- State
- OH
- ZIP
- 45237
- Country
- US
Regulatory Submissions
- 510(k) Number
- K042744
Owner / Operator
- Firm Name
- Guerbet LLC / Liebel-Flarsheim Company LLC
- Operator Number
- 10050387
- Address
- 214 Carnegie Center, Suite 300
- City
- Princeton
- State
- NJ
- Postal Code
- 08540
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Injector And Syringe, Angiographic | DXT | Class 2 | Cardiovascular | No | 2015-11-13 |
Proprietary Names
OptiVantage DH Power Injection System
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility