FDA Registration
Active
🇨🇷 Costa Rica
Guidewire Traxcess 14EX
Reg #: 3010432890
·
FEI: 3010432890
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Sterigenics Costa Rica S.R.L.
- Registration Number
- 3010432890
- FEI Number
- 3010432890
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Zona Franca PROPARK, Calle Principal, Edificio 10
- City
- El Coyol Alajuela
- Country
- CR
Regulatory Submissions
- 510(k) Number
- K093397
Owner / Operator
- Firm Name
- Sotera Health LLC
- Operator Number
- 10029425
- Address
- 2015 Spring Road, Suite 650
- City
- Oak Brook
- State
- IL
- Postal Code
- 60523
- Country
- US
- Correspondent
- Karen Whaley-Krumins
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Wire, Guide, Catheter | DQX | Class 2 | Cardiovascular | No | 2013-11-14 |
Proprietary Names
Guidewire Traxcess 14EX
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)