FDA Registration
Active
🇺🇸 United States
HexaVue Integration System (RM-MF)
Reg #: 1043572
·
FEI: 1043572
·
Expires 2025
Products
1
Proprietary Names
12
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- STERIS CORPORATION
- Registration Number
- 1043572
- FEI Number
- 1043572
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2720 GUNTER PARK DRIVE EAST
- City
- MONTGOMERY
- State
- AL
- ZIP
- 36109
- Country
- US
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 |
|---|---|---|---|---|---|
| Light, Surgical, Accessories | FTA | Class 2 | General, Plastic Surgery | No | 2020-10-10 |
Proprietary Names
HexaVue Integration System (RM-MF)
HV 1000
IDSS-SLC (version 7 and 8) (RM-CFE)
Harmony iQ 2400-SLC (RM-CFE)
Harmony iQ 2800-SLC (RM-CFE)
Sterile Light Handle Cover (MG-SD, SLDC-RR)
Harmony iQ 3600-SLC (RM-CFE)
HexaVue Integration System-Surgical Light Control (RM-MF)
Sterile Handle Camera Cover (MG-SD, SLDC-RR)
Universal Light Handle Cover (MG-SD, SLDC-RR)
HexaVue IP In-Light Control Systems (RM-MF)
HexaVue IP Integration System (RM-MF)
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility