FDA Registration Active 🇺🇸 United States

VASCADETM 6/7F Vascular Closure System

Reg #: 2029275 · FEI: 1000306431 · Expires 2025
Products
1
Proprietary Names
6
Establishment Types
1
Classifications
1

Registration Details

Registration Name
Sterigenics U.S., LLC
Registration Number
2029275
FEI Number
1000306431
Status
Active
Expiry Year
2025
Initial Importer
No
Address
344 Bonnie Cir
City
Corona
State
CA
ZIP
92878
Country
US

Regulatory Submissions

PMA Number
P120016

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, Hemostasis, Vascular MGB

Proprietary Names

VASCADETM 6/7F Vascular Closure System VASCADETM 5F Vascular Closure System VASCADE 6/7F VASCADE MVPTM 6-12F Venous Vascular Closure System VASCADE MVP VASCADE 5F

Establishment Types

Sterilize Medical Device for Another Party (Contract Sterilizer)