FDA Registration
Active
🇺🇸 United States
Irrigation Kit CO2 Long (00711556, 00711559) (EN-MF)
Reg #: 1528319
·
FEI: 1000122656
·
Expires 2025
Products
1
Proprietary Names
5
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- UNITED STATES ENDOSCOPY GROUP, INC.
- Registration Number
- 1528319
- FEI Number
- 1000122656
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 5976 Heisley Rd
- City
- Mentor
- State
- OH
- ZIP
- 44060
- 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 |
|---|---|---|---|---|---|
| Gastric Irrigation And Aspiration Kit | PRT | Class 2 | Gastroenterology, Urology | No | 2020-10-29 |
Proprietary Names
Irrigation Kit CO2 Long (00711556, 00711559) (EN-MF)
Irrigation Kit CO2 Short (00711555, 00711558) (EN-MF)
BioGuard air/water & suction valves-Olympus (4 pc kit) (00711784) (EN-SD)
BioGuard air/water & suction valves-Olympus (3 pc kit) (00711783) EN-SD)
Irrigation Kit Standard (00711554, 00711557) (EN-MF)
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device