FDA Registration
Active
🇨🇷 Costa Rica
Coaxial
Reg #: 3036802499
·
FEI: 3036802499
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Theragenics Costa Rica Limitada
- Registration Number
- 3036802499
- FEI Number
- 3036802499
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Building B28, Module B, Zone Franca Coyol
- City
- El Coyol, Alajuela
- Country
- CR
Regulatory Submissions
- 510(k) Number
- K172487
Owner / Operator
- Firm Name
- Theragenics Corporation
- Operator Number
- 1037598
- Address
- 5203 BRISTOL INDUSTRIAL WAY, --
- City
- Buford
- State
- GA
- Postal Code
- 30518
- Country
- US
US Agent
- Business Name
- Galt Medical
- Contact Name
- David Derrick
- Address
- 2220 Merritt Dr
- City
- Garland
- State
- TX
- ZIP
- 75041
- Country
- US
- [email protected]
- Phone
- 214 7781306
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Dilator, Vessel, For Percutaneous Catheterization | DRE | Class 2 | Cardiovascular | No | 2017-11-01 |
Proprietary Names
Coaxial
Establishment Types
Manufacture Medical Device