FDA Registration Active 🇺🇸 United States

AMSCO V-PRO 1 Low Temperature Sterilization System (MY-CFE)

Reg #: 3003950207 · FEI: 3003950207 · Expires 2025
Products
1
Proprietary Names
5
Establishment Types
1
Classifications
1

Registration Details

Registration Name
STERIS Corporation
Registration Number
3003950207
FEI Number
3003950207
Status
Active
Expiry Year
2025
Initial Importer
Yes
Address
6100 Heisley Rd
City
Mentor
State
OH
ZIP
44060
Country
US

Regulatory Submissions

510(k) Number
K162413

Owner / Operator

Firm Name
STERIS Corporation
Operator Number
10078069
Address
5960 Heisley Road
City
Mentor
State
OH
Postal Code
44060
Country
US

Products

Device Name Product Code
Sterilizer, Chemical MLR

Proprietary Names

AMSCO V-PRO 1 Low Temperature Sterilization System (MY-CFE) V-PRO 60 Low Temperature Sterilization System (MY-CFE) VAPROX HC Sterilant (PB007 and PB028) (MM-MF, CM-SD) AMSCO V-PRO maX Low Temperature Sterilization System (MY-CFE) AMSCO V-PRO 1 Plus Low Temperature Sterilization System (MY-CFE)

Establishment Types

Manufacture Medical Device