FDA Registration Active 🇺🇸 United States

No Sting Skin Protectant, 28 mL

Reg #: 1058584 · FEI: 1000219637 · Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3

Registration Details

Registration Name
Sterigenics US LLC
Registration Number
1058584
FEI Number
1000219637
Status
Active
Expiry Year
2025
Initial Importer
No
Address
10811 Withers Cove Park Drive
City
Charlotte
State
NC
ZIP
28278
Country
US

Regulatory Submissions

510(k) Number
K160184

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
Transducer, Ultrasonic, Diagnostic ITX
System, Imaging, Pulsed Doppler, Ultrasonic IYN
System, Imaging, Pulsed Echo, Ultrasonic IYO

Proprietary Names

No Sting Skin Protectant, 28 mL

Establishment Types

Sterilize Medical Device for Another Party (Contract Sterilizer)