FDA Registration
Active
🇺🇸 United States
Henry Schein Integrator (FP-CM,HP-CM)
Reg #: 3007412809
·
FEI: 3007412809
·
Expires 2025
Products
1
Proprietary Names
11
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- STERIS Corporation
- Registration Number
- 3007412809
- FEI Number
- 3007412809
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 11457 MELROSE AVE
- City
- FRANKLIN PARK
- State
- IL
- ZIP
- 60131
- Country
- US
Regulatory Submissions
- 510(k) Number
- K063799
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 | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Indicator, Physical/Chemical Sterilization Process | JOJ | Class 2 | General Hospital | No | 2020-10-12 |
Proprietary Names
Henry Schein Integrator (FP-CM,HP-CM)
SPS SteamPlus Steam Integrator Ster-All Performance Steam Sterilization Integrator (FP-CM,HP-CM)
McKesson Steam Integrator (FP-CM,HP-CM)
MCKESSON STERILIZATION INTEGRATOR (FP-CM,HP-CM)
SPS INTEGRATORS (FP-CM,HP-CM)
SPS Henry Schein Integrator (FP-CM,HP-CM)
K-Dental Indicators (FP-CM,HP-CM)
Patterson Type 5 (FP-CM,HP-CM)
SPS EMULATING INDICATORS (FP-CM,HP-CM)
HENRY SCHEIN MAXITEST INTEGRATORS (FP-CM,HP-CM)
SPS ENSURE (FP-CM,HP-CM)
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)