FDA Registration
Active
🇺🇸 United States
SmartBand Ligation Kit (EN-MF, IE-SD)
Reg #: 1528319
·
FEI: 1000122656
·
Expires 2025
Products
1
Proprietary Names
4
Establishment Types
1
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 |
|---|---|---|---|---|---|
| Ligator, Esophageal | MND | Class 2 | Gastroenterology, Urology | No | 2024-01-05 |
Proprietary Names
SmartBand Ligation Kit (EN-MF, IE-SD)
SmartBand SafeGrip Multi-Band Ligation Pack (EN-MF, IE-SD)
SmartBand Ligation Pack (EN-MF, IE-SD)
SmartBand SafeGrip Multi-Band Ligation Kit (EN-MF, IE-SD)
Establishment Types
Manufacture Medical Device