FDA Registration
Active
🇨🇷 Costa Rica
SureForm 45 (Stapler 45) Curved-Tip Instrument - 480545
Reg #: 3010432890
·
FEI: 3010432890
·
Expires 2025
Products
3
Proprietary Names
2
Establishment Types
1
Classifications
3
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
- K222839
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 |
|---|---|---|---|---|---|
| Staple, Implantable | GDW | Class 2 | General, Plastic Surgery | No | 2025-02-25 |
| System, Surgical, Computer Controlled Instrument | NAY | Class 2 | Gastroenterology, Urology | No | 2025-02-25 |
| Stapler, Surgical | GAG | Class 2 | General Hospital | No | 2025-02-25 |
Proprietary Names
SureForm 45 (Stapler 45) Curved-Tip Instrument - 480545
Stapler Reload SureForm 45 (Blue) - 48245B
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)