FDA Registration
Active
🇺🇸 United States
STRYKER TOURNIQUET CUFF 12 X 2
Reg #: 2011171
·
FEI: 2011171
·
Expires 2025
Products
1
Proprietary Names
33
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Sterigenics US LLC
- Registration Number
- 2011171
- FEI Number
- 2011171
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 4900 Gifford Ave
- City
- Los Angeles
- State
- CA
- ZIP
- 90058
- Country
- US
Regulatory Submissions
- 510(k) Number
- K890014
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, Pneumatic | KCY | Class 1 | General, Plastic Surgery | No | 2012-12-06 |
Proprietary Names
STRYKER TOURNIQUET CUFF 12 X 2
STRYKER TOURNIQUET CUFF 24 X 5.5
STRYKER TOURNIQUET CUFF 54 X 6?, 2/1/QUICK
STRYKER TOURNIQUET CUFF 9 X 1.75?, 1/1/QUICK
STRYKER TOURNIQUET CUFF 24 X 4?, 2/1/QUICK
STRYKER TOURNIQUET CUFF 54 X 6?,2/1/LUER
STRYKER TOURNIQUET CUFF15 X 2.5
STRYKER TOURNIQUET CUFF 9 X 2.75?, 2/1/QUICK
STRYKER TOURNIQUET CUFF 18 X 4?, 2/1/LUER
STRYKER TOURNIQUET CUFF 9 X 2.75
STRYKER TOURNIQUET CUFF 18 X 5.5
STRYKER TOURNIQUET CUFF 18 X 3?, 2/1/QUICK
STRYKER TOURNIQUET CUFF 44 X 4?, 1/1/QUICK
STRYKER TOURNIQUET CUFF 18 X 4
STRYKER TOURNIQUET CUFF 9 X 1.75?, 1/1/LUER
STRYKER TOURNIQUET CUFF12 X 3.5
STRYKER TOURNIQUET CUFF15 X 2.5?, 2/1/QUICK
STRYKER TOURNIQUET CUFF 34 X 4
STRYKER TOURNIQUET CUFF 24 X 5.5?, 2/2/LUER
STRYKER TOURNIQUET CUFF 18 X 3?, 2/1/LUER
STRYKER TOURNIQUET CUFF 18 X 4?, 2/1/QUICK
STRYKER TOURNIQUET CUFF12 X 3.5?, 2/1/LUER
STRYKER TOURNIQUET CUFF 30 X 4
STRYKER TOURNIQUET CUFF 9 X 1.75?, 2/1/LUER
STRYKER TOURNIQUET CUFF 12 X 2?, 2/1/LUER
STRYKER TOURNIQUET CUFF15 X 2.5?, 2/1/LUER
STRYKER TOURNIQUET CUFF12 X 2?, 1/1/QUICK
STRYKER TOURNIQUET CUFF 44 X 4
STRYKER TOURNIQUET CUFF 18 X 3
STRYKER TOURNIQUET CUFF 9 X 1.75?, 2/1/QUICK
STRYKER TOURNIQUET CUFF 24 X 4?, 2/1/LUER
STRYKER TOURNIQUET CUFF12 X 2?, 2/1/QUICK
STRYKER TOURNIQUET CUFF 24 X 4
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)