FDA Registration
Active
🇺🇸 United States
Flask, Baffled, PETG
Reg #: 1526534
·
FEI: 1526534
·
Expires 2025
Products
1
Proprietary Names
4
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Sterigenics US, LLC
- Registration Number
- 1526534
- FEI Number
- 1526534
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 305 Enterprise Dr
- City
- Lewis Center
- State
- OH
- ZIP
- 43035
- Country
- US
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 |
|---|---|---|---|---|---|
| Flask, Tissue Culture | KJA | Class 1 | Hematology | No | 2009-08-14 |
Proprietary Names
Flask, Baffled, PETG
Vented Sterile Disposable Flask
Disposable PETG Flask, Plain Bottom, 2800ml, Vented Closure
Disposable PETG Flask, Baffled Bottom, 2800ml, Standard Closure
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)