FDA Registration Active 🇺🇸 United States

Algidex Dermanet

Reg #: 2029275 · FEI: 1000306431 · Expires 2025
Products
1
Proprietary Names
8
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

510(k) Number
K884422

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
Dressing, Wound, Drug FRO

Proprietary Names

Algidex Dermanet Algidex AG Algidex Thin Film Algidex Paste Algidex IV impregnated gauze dressings intended for use as a primary contact layer in dressing wounds. oil emulsion, xeroform, petr Multidex Powder (various) Multidex Powder

Establishment Types

Sterilize Medical Device for Another Party (Contract Sterilizer)