FDA Registration Active 🇺🇸 United States

MasterGraft Matrix (MGM)

Reg #: 1319639 · FEI: 1000138054 · Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1

Registration Details

Registration Name
Sterigenics U.S., LLC
Registration Number
1319639
FEI Number
1000138054
Status
Active
Expiry Year
2025
Initial Importer
No
Address
84 Park Rd
City
Queensbury
State
NY
ZIP
12804
Country
US

Regulatory Submissions

510(k) Number
K023553

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
Filler, Bone Void, Calcium Compound MQV

Proprietary Names

MasterGraft Matrix (MGM)

Establishment Types

Sterilize Medical Device for Another Party (Contract Sterilizer)