FDA Registration
Active
🇺🇸 United States
Finale Vascular Compression Device
Reg #: 1721676
·
FEI: 1721676
·
Expires 2025
Products
1
Proprietary Names
29
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Sterigenics U.S., LLC
- Registration Number
- 1721676
- FEI Number
- 1721676
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 5725 Harold Gatty Dr
- City
- Salt Lake City
- State
- UT
- ZIP
- 84116
- 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 |
|---|---|---|---|---|---|
| Tourniquet, Nonpneumatic | GAX | Class 1 | General, Plastic Surgery | No | 2012-11-12 |
Proprietary Names
Finale Vascular Compression Device
19017/20
4928/25
4908/24
4905/24
4918/100
4902/20
4904/10
4912/20
19040/24
4910/25
4908/10
19016/10
19090/24
19014/10
04902/10
19022/20
19011/10
4906/25
4920/10
4909/20
04903/10
4918/25
4903/24
04902/25
FCP01-4" EMERGENCY BANDAGE, REV. B
FCP01-4" EMERGENCY BANDAGE, REV. B U.S.
FCP02-6" EMERGENCY BANDAGE, REV. B
TOURNIQUET
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)