FDA Registration
Active
🇺🇸 United States
ORLocate Sponge System
Reg #: 1043572
·
FEI: 1043572
·
Expires 2025
Products
1
Proprietary Names
1
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
Regulatory Submissions
- 510(k) Number
- K100551
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 |
|---|---|---|---|---|---|
| Counter, Sponge, Surgical | LWH | Class 1 | General Hospital | No | 2025-03-09 |
Proprietary Names
ORLocate Sponge System
Establishment Types
Manufacture Medical Device